News Items 

July 2020

Bristol Trials Centre (BTC) Webinars and Presentations – July 2020 

Trial managers from the Bristol Royal Infirmary (BRI) Hub of the BTC will be giving virtual presentations and webinars as part of the UKTMN (UK Trial Management Network).  

Trial Methodology Research Partnership (TMRP) webinar series (22nd July) 

Maddie Clout and Hana Tabusa will present “Are electronic study management systems acceptable to participating sites?”. You can see the recording of this webinar here. 

Rapid Presentation: Changes to Clinical Trials as a Result of COVID-19 (23rd July)  

  • "A multi-centre CTIMP: moving from hard copy and face-to-face, to online” (Abby O'Connell) 

  • “The advantages of electronic study management systems when working from home during the COVID-19 pandemic” (Maddie Clout and Hana Tabusa) 

  • “Alternative methods of serious adverse event reporting during remote working” (Maddie Clout and Sarah Baos)  

A recording of the rapid presentation event can be seen here.

This is a great demonstration of the innovation shown by BTC Trial Managers.  


June 2020

BTC Research Nurses and Administrators 

Whilst most of the BTC is working from home during the COVID-19 pandemic, the research nurses along with the research admin team are working hard at the Bristol Royal Infirmary keeping things going, carrying out tasks such as sorting the post, carrying out patient follow up and sending out questionnaires, and we would like to thank them for thier ongoing hard work.

Karen Sheehan, the paediatric research sister, has found that for her as the ‘manager it’s been lots of planning and preparation for different scenarios as they arise.  Supporting my team to ensure they are fully aware of the latest information, are happy with new processes with study delivery and generally checking in on how we’re all doing.  I know I have my moments and am lucky that the support works both ways.  Also, the support of our lovely university colleagues with little surprise deliveries has been so appreciated. ‘

We know that research nurses around the country working on BTC studies are working in challenging conditions at the moment. We hope you are all keeping well and look forward to working with you on our studies again soon.


May 2020

Results of the IVAN Follow-up trial have been published

The results of the IVAN Follow-up study have recently been published in the Ophthalmology journal. The IVAN Follow-up study was, as it’s name suggests, the follow-up study to the original IVAN trial which was published in The Lancet back in 2013. 

Participants in the IVAN Trial were randomised to receive one of two anti-VEGF treatments, Lucentis or Avastin, directly into their affected eye to treat ‘wet’ age-related macular degeneration (AMD), one of the biggest causes of sight loss in the UK. The IVAN Follow-up trial, managed by Dawn Phillips, collected data from the majority of the original IVAN participants from the time between their exit from the IVAN Trial up to 7 years later.

The results of the IVAN Follow-up trial showed:

  • Distance visual acuity (letters read on a letter chart) worsened by more than 4 letters per year;
  • Approximately one third of eyes with AMD treated with anti-VEGF treatments retained a level of vision that was sufficient for driving;
  • The anti-VEGF injection rate (i.e. how frequently patients had injections) did not influence the rate of change in distance visual acuity.

A major strength of IVAN Follow Up was the exceptional data completeness, much of which was extracted from medical records spanning up to 7 years. Research staff commented on the strong bonds they had formed with patients over the course of the original IVAN trial whilst many patients reported a strong desire to contribute to IVAN Follow Up. Undoubtedly, this sense of belonging that staff and patients developed during the IVAN trial led to excellent adherence during IVAN Follow Up. The results that they contributed to have important implications for clinicians with regards to patient counselling and treatment planning and for healthcare providers with regards to planning and resource allocation.

A brief history

The IVAN trial was the first multi-centre CTIMP led by what was formerly the CTEU Bristol (now the Bristol Trials Centre) and it had a huge impact on ophthalmology research in the NHS. Many new collaborations have been formed and countless papers have come out of this work and the work that stemmed from it. The IVAN Trial also put the CTEU in an excellent position to take on and manage many more ophthalmology studies since. The IVAN Follow-up study was funded by the NIHR HTA Programme (project number 07/36/501). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR HTA or the Department of Health and Social Care.


 BTC collaborator COVID-19 projects

The Bristol Trials Centre has many collaborators who work with us on our studies, providing specific support and guidance. We have highlighted below some of the great research that BTC collaborators are carrying out into COVID-19.

The DECIDE study - DEcision making about Cancer treatment during the covID 19 pandEmic.

Led by Daisy Elliott

The overall aim of this project is to investigate formulation and delivery of cancer treatment recommendations in the context of the COVID-19 pandemic, with a view to producing evidence-informed resources to support communication in clinician-patient encounters.

Specific objectives are to:

  • Investigate processes for organising and prioritising cancer treatment during the COVID-19 pandemic in NHS Trusts across the UK, including clinical professionals’ experiences of implementing national and specialty-specific guidance;
  • Examine cancer treatment discussions conducted between clinical professionals and patients through audio-recording clinical consultations;
  • Explore patients’ and clinical professionals’ experiences of the above clinical encounters and their perceptions of how these can be improved;
  • Use the evidence generated from the above to produce resources designed to support communication around cancer treatment in the context of the COVID-19 pandemic.

The Lotus C19 Study - Understanding perceptions of risks, mitigation and innovation for surgery in a COVID-19 world.

Led by Leila Rooshenas

We will conduct in-depth, semi-structured interviews to understand the perceived risks in surgery in the context of COVID-19 and explore strategies to overcome these. We will examine present experiences in the NHS and the international response by surgical teams.

COVID-19 rapid evidence reviews - co-ordinated by the National Institute for Health Research Applied Research Collaboration West (NIHR ARC West).

The Bristol Trials Centre is one of several research centres from across the University of Bristol, University of the West of England and University of Bath to be collaborating with NIHR ARC West to provide rapid evidence reviews for COVID-19 response planning. These reviews offer expertise across various settings and topics to inform decision-making for NHS clinical commissioning groups (CCGs), local authority public health departments and the Department of Health and Social Care in their response to the COVID-19 pandemic. Settings include mental health, primary care, care homes, acute trusts and community, with a range of topics covered across those settings. Dr Peter Brindle, Medical Director at the Bristol, North Somerset and South Gloucestershire CCG, said: “These rapid reviews are just one example of how the academic community has rallied to support the health and care system in the COVID-19 crisis. It is incredible how responsive university colleagues have been in providing evidence and evaluation support.” The rapid evidence reviews are available on the NIHR ARC West website:


Fiona Lithander has written a blog on the need for more research in older adults 



April 2020

MONARCH study recruitment ends

The recruitment period for the MONARCH study has ended with a total of 297 participants and has now entered a 6-month follow-up phase.

The MONARCH study is investigating the diagnostic accuracy of three home-based vision tests that are completed by patients with neovascular age-related macular degeneration (nAMD) at home each week. nAMD is the leading cause of blindness in the UK and can transition between being active and inactive. Therefore, regular visits to an NHS eye clinic is required to determine whether or not an eye is active and needs treatment. If a test completed by the patient at home was able to accurately detect if an eye needed treatment, clinic appointments could be reserved for patients likely to require treatment. This would be more convenient and less costly for the patients and the NHS.

The 3 tests being investigated include two electronic tests on an iPod Touch and one paper-based test. As of 27th April, 13,579 electronic tests and 283 paper test diaries have been received. Participants in the study will continue completing the tests each week until the end of follow-up in September this year. There is also a qualitative component to the study investigating the acceptability of the tests by interviewing participants, carers and healthcare professionals. So far, 61 interviews have been completed.

The MONARCH protocol article was published with open access in Eye on 4th May 2020 and can be found here:

This study is funded by the NIHR Health Technology Assessment (HTA) Programme (15/97/02). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Study coordinator: Robin Wickens

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March 2020

Top Tips for Working from Home

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The BTC have moved to working from homefor the benefit of everyone whilst the COVID-19 pandemic is ongoing. As this could be our new normal for quite some time, the News Group thought they would share their top tips for happy and productive home-based working in these unusual times. Of course, we are so thankful to those who are continuing to work on the frontline through this time.

       Create a Routine

Coming up with a new working from home routine will give some structure to your day, to help prevent the lines between home and work becoming blurred! Getting dressed in what you normally wear to work and starting your work day at the usual time will help you to get in the ‘working headspace’. This routine should also include breaks away from your desk, including a lunch break (possibly involving some exercise), and finishing at a set time

  Working Environment

Having a dedicated workspace is good for helping you focus and feel more in the ‘work zone’. If possible, you can make your workspace nicer with a comfortable chair, some fresh air and maybe a pot plant.

       Maintain Social Connections

Keep in touch with your office friends and colleagues and have ad hoc conversations outside of emails, just like you would at work – Whatsapp video calling is great for this. The BRI-Hub held a virtual tea break on Zoom recently to help with social contact – this isn’t something we would normally do at work, but it’s important to meet without an agenda. You could also try joining meetings early to have a little chat with others before the meeting starts, similar to when you get to a meeting a bit early at the office.


This is a new way of working for us all, especially for those who are caring for others and parents who are now teachers! Try to relax and be kind to yourself; don’t feel guilty if you can’t put in the same hours you normally would; if you have lots going on at home the University’s message is to “do your best”. It will take some time to identify habits which lead to the most productivity and to feel comfortable in your new work environment. 

   Understand Expectations

Keep in regular touch with your line manager and project team members to make sure you all have clarity on expectations for your projects at this unusual time, especially when trying to make sure you have boundaries in place around your work day. You can use tools such as OneNote or SharePoint to set up project task pages that you can share with your team so you all know what tasks are ongoing.


Try to stay positive! There are lots of new skills to be learned from this new way of working that will make us all better at our jobs in the long run. It can also be helpful to focus on what you can control, and plan for various possibilities that you can foresee. 

 Reach Out if You Need Help

It’s ok to have off days and some will find this new situation harder than others. Remember to reach out if you need help or someone to talk to. The BTC is a community and we are all in this together!


NIHR put out a Signal to the VICI Trial

The results of the VICI Trial were published in The Lancet earlier this year – a significant achievement for all involved at Bristol Trials Centre. More recently, the NIHR selected the VICI Trial for one of their Signal pieces, highlighting the importance of this work to the NIHR and the community.

The VICI Trial found that the heart failure drug, eplerenone, showed no benefit for treating the eye disease chronic central serous chorioretinopathy (CSCR). Eplerenone has been widely prescribed off licence for this condition based on the results of a few small trials and anecdotal evidence. The VICI Trial was the first randomised controlled trial with adequate power to evaluate the efficacy of eplerenone for CSCR. Based on the results of the trial, it is strongly recommended that eplerenone is no longer prescribed for CSCR.

Trial manager, Abby O’Connell said, “It’s really satisfying to have been involved in a clinical trial that had such a clear and clinically important outcome and the team are really pleased that our work has been recognised in this way”.


HTA 15/80/52 - The High-volume Haemodiafiltration vs High-flux Haemodialysis Registry Trial (H4RT)

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Trial Manager: Dr Sunita Procter (@sunitaprocter)

Chief Investigator: Dr Fergus Caskey (@fjcaskey)


This trial aims to establish the effectiveness of haemodialysis versus haemodiafiltration in the treatment of kidney disease. End stage kidney disease affects around 65,000 people in the UK. Almost half of these people will have blood cleaning treatment known as haemodialysis (HD) at a hospital.

The addition of filtration (the removal and replacement of fluid) to regular haemodialysis is known as haemodiafiltration (HDF). This does not change the dialysis procedure from the patient perspective, as it is still 4 hours 3 times a week, but it does require a change in equipment and nurse practice. 

By removing toxins more effectively, HDF may reduce infection rates, and improve survival and quality of life of patients.

H4RT is a non-blinded Randomised Controlled Trial comparing the clinical and cost-effectiveness of high-volume HDF compared with high-flux HD in the treatment of end stage kidney disease. 

H4RT have recruited 1038 patients (67%) of the target 1550 patients from 28 sites in the UK since opening in November 2017, with recruitment until 31 March 2021. There is a H4RT Investigator meeting planned for the 16 September 2020 at Wills Hall, Bristol.

Twitter handle: @H4RT_UK


NIHR Statistics Routine Data Group

On 4 March 2020, BTC welcomed over 50 delegates to the third NIHR Statistics Routine Data Group workshop, supported by Bristol BRC. The topic for the workshop was "routine data within clinical trials" and alongside an welcome and overview of BTC studies, speakers from Oxford University, Imperial College, Kings College London and UCL gave interesting presentations on their experiences, challenges faced and lessons learned from undertaking efficient trials utilising routine data. There was plenty of networking and good discussions. Plans are in place for developing joint publications that would benefit Statisticians who are new to working with routine data.

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Third GAP Investigators' meeting

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The third GAP study Investigators’ meeting was held recently. It was a great opportunity for GAP study teams from different sites to meet, 
offer tips and share experiences to support each other in the running of the trial. There was a lot of positive feedback from the meeting; 
attendees reported that the meeting improved their knowledge about the study, they found it useful and felt included and able to ask questions.

Currently, patients are prescribed opioids such as morphine after surgery to provide pain relief. The GAP study aims to find out whether prescribing the drug gabapentin, alongside opioids and other drugs, improves pain control and leads to fewer side effects overall and a quicker recovery. The study is recruiting patients having heart, thoracic (e.g. lung) or abdominal surgery and has currently recruited over 800 participants – over halfway to our target! We are extremely grateful to all staff and patients who have been involved so far. A big thank you also goes out to all patients who are currently completing their follow up questionnaires by post and over the phone, we really appreciate your time and effort in making this study a success.

For more information about the GAP study please visit our website.

This study is funded by the National Institute for Health Research - Health Technology Assessment Programme (15/101/16). The views and opinions expressed therein are those of the author(s) and not necessarily reflect those of the National Institute of Health Research, NHS, or the Department of Health and Social Care.



February 2020

The first SISMIC Investigator’s meeting was held on 20th February 2020.

Up to 10,000 symptomatic articular cartilage injuries occur in the UK each year and treatments aim to either restore or replace the articular cartilage. Cartilage restoration often uses microfracture with or without scaffold insertion. Microfracture involves penetrating the subchondral bone in the area of injury to release fibrin and stem cells, which leads to the development of cartilage with scar tissue. It has been suggested that results may be better if a scaffold is used to help the repair.

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The SISMIC study will investigate the clinical and cost-effectiveness of microstructural scaffold insertion following microfracture versus microfracture alone for the treatment of patients with chondral knee defects.

The Investigators meeting incorporated cadaveric training which was funded and provided by Joint Operations (one of the scaffold suppliers). Surgeons were able to practice the techniques which will be used in the study. Representatives from Baxter and Conmed attended and provided training on the use of the Tisseel glue which can be used in place of sutures to fix the scaffold in place. The meeting also allowed investigators from sites to meet with the wider research team. 

This study is funded by the National Institute for Health Research-Health Technology Assessment Programme (NIHR127849). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.



Study Manager: Holly McKeon 


The PURSUIT study is now open to recruitment!

Proper Understanding of Recurrent Stress Urinary Incontinence Treatment in women: a randomised controlled trial of endoscopic and surgical treatment

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The PURSUIT study is a NIHR-HTA funded (17/95/03) two-arm trial randomising women with recurrent, or persistent, stress urinary incontinence (SUI) to endoscopic urethral bulking injections or a surgical operation. There is currently no good evidence about which is the most effective treatment for improving symptoms and quality of life in women with this condition. We plan to recruit 250 participants from 24+ NHS hospitals throughout the UK and the study will run for 6 years. 

Latest News

  • Our first 3 pilot sites open to recruitment - North Bristol NHS Trust, Birmingham Women's and Children's NHS Foundation Trust and NHS Ayrshire & Arran have all opened to recruitment in the last 6 weeks. 
  • Two further sites are due to open in early March completing our target of 5 pilot sites. 
  • North Bristol NHS Trust have recruited our first 2 participants to the study – fantastic work!  
  • In April & May we will be training 19 new NHS sites to join the main phase of the study, bringing our total number of recruiting sites to 24.

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(Above) PURSUIT study training day

For further info:



Twitter: @PursuitTrial

Trial Manager: Dr. Caroline Pope
Trial Administrator: Miss Lucy Clark


FITNET-NHS: the biggest Paediatric Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) Trial

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Most UK children with Chronic Fatigue Syndrome (CFS/ME) have no access to local specialist treatment. FITNET-NHS tests the delivery of specialist one-to-one home treatments via the Internet, bringing treatment to families across the UK without the need for travel. All children in the trial are offered one of two treatments from a specialist at the Bath Paediatric CFS/ME Service:

  •   FITNET-NHS, a Cognitive Behavioural Therapy (CBT) program - delivered online
  •   Activity Management - delivered via Skype

The FITNET-NHS Trial has now become the world's biggest Paediatric Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) Trial. The FITNET-NHS trial has recruited 246 participants and we aim to recruit a total of 314 participants by the end of October 2020.

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The study is led by Prof Esther Crawley and the research team (Dr Emma Anderson, Mrs Manmita Rai and Dr Roxanne Parslow) who are all based at The Centre for Academic Child Health, Population Health Sciences, University of Bristol. The study is funded by the National Institute of Health Research (NIHR) and is sponsored by the University of Bristol. For more info, please click here.  


ELICIT Consensus Meeting

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Maddie Clout, a trial manager from the BTC, recently attended a consensus meeting for the development of a core outcome set relating to the evaluation of interventions for informed consent for randomised controlled trials (ELICIT). Core outcome sets define a group of outcomes which all trials in a certain research area should collect, allowing the results of those trials to be more easily compared. The meeting was held at the University of Aberdeen and funded by the Medical Research Council.

The group of triallists, statisticians and members of the public met following a previous literature review and Delphi process, which had identified and ranked 43 potential outcomes across themes including the experience of decision-making and participant characteristics. The group worked together to reach a consensus on which of these 43 items should form the final core outcome set, and so be collected by all future trials in this research area. Maddie said “It was fascinating to hear insights from the diverse group, and see areas in which triallists and patients ranked the importance of outcomes very differently from each other!” Fuelled by coffee and pastries, the group came to a consensus and a final list of outcomes was agreed upon, which will be published in the near future.

If you want to find out more about core outcome sets, the COMET Initiative have produced an animation which can be seen here.




January 2020

Bristol Trials Centre publish trial results in The Lancet

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The Bristol Trials Centre recently published the results of one of the clinical trials managed by the Centre in The Lancet. The VICI Trial investigated the safety and efficacy of a heart drug, eplerenone, for treating an eye condition called chronic central serous retinopathy (CSCR). Eplerenone is licenced to treat heart failure but is widely prescribed for chronic CSCR despite limited evidence of its efficacy. In this blinded, placebo-controlled randomised trial, 114 participants were assigned to take tablets containing either eplerenone or a placebo once daily for up to 12 months, with regular hospital visits to have assessments of their vision, eye anatomy and quality of life. The primary outcome was visual acuity (i.e. ability to read letters on a letter chart) at 12 months.

The results showed that participants in the eplerenone group did no better than those in the placebo group in any of the outcomes assessed. Therefore, there is no benefit of taking eplerenone for the treatment of chronic CSCR. This was an important finding as eplerenone is currently being used widely to treat this condition with no proven benefit. Our aim now is to ensure the results are disseminated far and wide to stop the prescribing of eplerenone for chronic CSCR before it becomes embedded in practice.

The results of the trial have been fed back to participants and, in addition to the Lancet paper, we have disseminated the results in other formats to ensure that the headline result is communicated to as many people as possible: an animated video created for YouTube has generated a lot of interest and a summary infographic has been created for dissemination to professional groups at conferences and training events. We have also publicised the trial widely through the BTC twitter account @BrsTrialsCentre.

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Click here to view the VICI Trial YouTube video!

Trial manager: Abby O’Connell

Chief investigator: Prof Andrew Lotery, consultant ophthalmologist, University of Southampton

Sponsor: University Hospitals Southampton NHS Trust. This project was funded by the Efficacy and Mechanism Evaluation (EME) Programme (13/94/15), an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.


The Bluebelle Study publishes another paper!

The Bluebelle Phase B results paper has been published - this brings the total papers from this feasibility study to 10! You can read the paper here: 




It has been a very busy end of 2019 across the Bristol Trials Centre, with a number of studies finishing thier recruitment phase, and some studies recruiting thier first patient, and some studies coming to an end.

November 2019

The Bristol Trials Centre (BTC), formed of the merger of the CTEU and the Bristol Randomised Trial Collaboration, was officially launched on the 5th November 2019, in an event at the Watershed. 

There were talks from the ROMIO, TRIUMPH and AIRWAYS-2 studies, highlighting the breadth of great work which is taking place across the centre. There was also a talk from guest speaker Kerry Hood (Director of the Centre for Trials Research, Cardiff) about the future of clinical trials.

You can see pictures from the event on our Twitter page: @BrsTrialsCentre 

October 2019

Bristol Trials Centre, formed from the merger of the CTEU and the BRTC will be launched on 5 November 2019 at the Watershed, Bristol.

Members of the CTEU and BRTC attended the recent Internation Clinical Trials Methodology Conference in Brighton, and really enjoyed meeting attendees from other trials centres, and hearing about all the exciting research that is taking place around the country. Our co-director Chris Rogers presenting the conferences closing remarks! 

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September 2019

The CTEU have had a great month, with two big studies closing to recruitment. You can read more about the ROMIO and the By-Band-Sleeve studies here: 

The SUNFLOWER study has opened 36 sites and the CIPHER study held their first Investigators meeting. 

Surgical site infection affects up to 20% of people with a primary closed wound after surgery. The BLUEBELLE study looked to evaluate the effectiveness & cost-effectiveness of dressing types to reduce SSI, and you can read the final report here:

August 2019

Surgical site infection affects up to 20% of people with a primary closed wound after surgery. The BLUEBELLE study looked to evaluate the effectiveness & cost-effectiveness of dressing types to reduce SSI, and you can read the final report here:

Barth Syndrome can cause an enlarged and weakened heart (dilated cardiomyopathy), and a risk of heart failure. The CARDIOMAN study is looking in to a drug to treat this. You can read more here:

July 2019

The PIPA health economics paper has been published! You can read it here: was a study into the cost-effectiveness for cardiovascular magnetic resonance (CMR) when patients activate the primary percutaneous coronary intervention (PPCI) pathway.

The VICI trial team had a fantastic final investigators meeting on the 11th July. The trial was very successful and ran to such a high quality, an amazing effort from the ophthalmology teams!

June 2019

June was a great month for study recruitment, with Sunflower recruiting the 300th patient, and CIPHER recruiting the 1000th! Both studies are continuing to work hard, opening lots of news sites, so hopefully the numbers will keep on adding up! 

May 2019

CTEU Research Nurses celebrated International Clinical Trials Day on the 22nd May. This is a day to celebrate James Lind, a surgeon in the British Royal Navy, who in 1747, compared different agents for their effectiveness in treating scurvy. Clinical research is now part of the core business of NHS organisations across the country.

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SUNFLOWER has reached over 150 recruitments, CIPHER over 800 and COMICS has 183 so far (as of the end of April) - well done to all three teams for such great work! 

April 2019

Today the 47th patient has been recruited to Thermic-3, and this means the study is halfway through, and on track to complete recruitment on time! 

The publication relating to the SKArF study has been published. This study looked at the inhibition of SK channel function as a possible therapeutic approach to treat atrial fibrillation (AF), and you can read it here: 

The first edition of the Bristol Trials Centre newsletter has been published. You can read more here

The CODEC study is now open to recruitment! CODEC will investigate change in brain resting state networks in those undergoing cardiac surgery with cardiopulmonary bypass using fMRI, and whether any changes correlate with changes in cognitive function

The Peacock Study has passed halfway in recruitment! Using a novel tissue microdialysis system to measure cortisol & other hormones dynamically without taking blood samples, the study looks at the stress response to cardiac surgery in children, to shape clinical practice

March 2019

On the 18th March the CIPHER study took part in the #crstrialschat on Twitter, discussing the study and parastomal hernias! 

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A paper on the ROMIO study Quality Assurance protocol has been published. You can read it here: 

February 2019

The PROMPT2 study is now open to recruitment! This study will investigate whether adding propofol to the cardioplegic solution in patients having isolated coronary artery bypass grafting (CABG) surgery using the heart-lung machine is beneficial and if the benefit is greater the more propofol that is used.

An AIRWAYS-2 paper looking at the challenges of the design and implementation of the trial in the Emergency Medical Services has been published in Trials. Read it here:

January 2019

2019 has already seen a milestone for the MARS 2 trial (Mesothelioma and Radical Surgery 2) with 200 patients now randomised, that’s over 60% of the 328 target!

The IVAN study  set out to compare Lucentis with Avastin in a randomised controlled trial, to find out whether Avastin is as clinically and cost-effective as Lucentis in treating nAMD. The results showed that Avastin, costing £28 per injection, was just as good as (neither worse nor better) Lucentis, (£561 per injection) in terms of the patients’ best corrected visual acuity. You can rad more about this study in a recent NIHR post here: 

You can also read more about working in research into eye health here: 


Could a new airway device be better than tracheal tube insertion for out-of-hospital resuscitation? There is a NIHR signal for the results of the AIRWAYS2 Study, which was coordinated by the CTEU, which you an read here:

Well done to the COMICS Trial team, who have recruited 60 patients so far! COMICS is comparing the number of complications in patients who have their operation using the conventional heart & lung machine and those having their operation using a miniaturised machine.

Study could benefit eye disease patients whilst saving NHS both time and money. Researchers from the University of Bristol, in collaboration with Queen's University Belfast, are leading a cutting-edge project, named the "MONARCH" study, that could benefit eye disease patients whilst saving both time and money within the NHS. You can read the full press release on the Universiry of Bristol Website here: 

November 2018

The CIPHER Study, which is looking into the risk of developing a parastomal hernia (PSH) as a result of a stome, has recruited 300 patients!

On Friday 16th November, the CTEU held a successful IVAN Follow Up Investigator Meeting, presenting the results of the extended follow up with Professor Usha Chakravarthy (CI) You can read more about this study here: 

The 2nd INSPIRE  Investigators Meeting in Southampton took place on the 22nd November. The study is currently in set-up, and is hoping to investigate whether a series of daily breathing exercises that aim to improve the strength and endurance of the muscles in the chest can help to reduce the chances of getting a lung complication after surgery.

October 2018

The MONARCH study featured on BBC Radio 4’s Inside Health with Dr Mark Porter on Tues 23rd October (9pm). 
Starring in the feature is Dr Ruth Hogg (study CI from Queen’s University Belfast) alongside Lesley Doyle (one of our fantastic study optometrists from the Ophthalmic Research Team at the Royal Victoria Hospital, Belfast) and a wonderful study participant recruited by the Belfast team, who kindly agreed to be interviewed about the study. 
The programme will also be available after broadcast on the BBC iPlayer radio application service.
The Thermic-2 Study Outcome paper has been published in Heart. You can read the article here: 

September 2018

The CTEU is proud to have managed the IVAN trial ( which showed Avastin® is as effective as Lucentis® for treating wet AMD. You can read more here:

You can watch a video of patients' experience of taking part in  the INFORM study  here: Researchers (including those from the CTEU), surgeons & patients have joined together to design & deliver the INFORM research study, looking at why some patients develop infections after their hip/knee replacement surgery. 

As part of the THERMIC-3 study, research staff are taking part in the TRECA (TRials Engagement in Children and Adolescents) study ( This study is a SWAT - Study Within A Trial, and is looking at the use of MMI (MultiMedia Information) when asking children and young adults to take part in trials.  

August 2018

The latest edition of the CTEU newsletter is now available here.

On the 20th August, Belfast Health and Social Care Trust recruited the first partcipant to the MONARCH study. This study is looking at the benefit of home monitoring to detect the need for treatment for patients with wet age-related macular degeneration (neovascular AMD, nAMD).

The AIRWAYS-2 study results paper has been published in The Journal of the American Medical Association (JAMA). The results show that the two most widely used techniques used by paramedics to support a patient’s breathing during cardiac arrest are similarly effective. You can read the whole article here, and find the infographic here

July 2018

The Violet Study has opened a sub-study, which aims to determine an association between cancer DNA in the blood and disease recurrence and survival to 5 years. The first patient has been recruited to the study - a huge well done to VIOLET study team for all their hard work with the set up of this sub-study!

The first Sunflower investigators meeting was held on the 6th July in Birmingham, with representatives from over 20 hospitals attending to input to the planning of the study. 

The OMACS study has contributed more than 10% to the University Hospital Bristol NHS Trust’s overall recruitment figures and was the second highest recruiting study in the region at the end of April 2018, thanks to the dedication of the cardiac surgery research nurses. 

June 2018

The Bristol CTEU is registered to take part in Round 7 of the NIHR Clinical Trials Fellowships. These fellowships are designed to support existing NIHR Trainees with an interest in, and experience of, working with clinical trials as part of their current training award who would benefit from further training within the setting of a Clinical Trials Unit (CTU). The scheme is now open for applications, and you can find out more here:

Our co-director Professor Chris Rogers hosted a webinar titled 'Audio-recording recruitment consultations – an exploratory study in two RCTs to investigate the impact on randomisation rates' on the 29th May, as part of the HTMR Trial Conduct Working Group webinars series. You can watch the webinar here: 

On the 11th June, Bristol CTEU hosted the first meeting of the South West Research Hub, bringing together trial coordinators, assistant coordinators, data managers and other staff in trial related roles from 6 Clinical Trial Units in the South West of England. The day included an overview of the work of the 6 Clinical Trial Units, presentations, and workshops on the themes of Studies within Trials and Recruitment Interventions as well as opportunities for networking and a poster session. The keynote speaker will be Shaun Treweek, discussing the work of Trial Forge

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The By-Band-Sleeve Study was featured on ITV West Country News. This clip explains the three different options that are available, and how it is hoped that the study will help health professionals know which of these three operations is the most effective for long-term weight loss and improvement of health problems and quality of life.

May 2018

Two New Studies Open to Recruitment

The GAP study has opened to recruitment this month. Opioids (e.g. morphine) are typically prescribed to control pain after surgery, which is key to recovery. Opioids are effective but carry side effects such as sleepiness, sickness and low blood pressure, which prevent recovery and keep patients in hospital for longer. Gabapentin is an alternative medication that doctors are increasingly prescribing for pain relief after surgery. We don’t know whether giving gabapentin alongside opioids and other drugs improves pain control, leading to fewer side effects overall and a quicker recovery.  This is the question the GAP study is aiming to answer.

The COMICS study, an international study, has also opened to recruitment.  This study will look at miniaturised heart lung machines (minimally invasive extra-corporeal circulation; MiECC) which have been developed with the aim of reducing the number of post-operative complications arising from using conventional extra-corporeal circulation; CECC. The effectiveness of MiECC in reducing post-operative complications has not been established and most hospitals continue to use CECC. The COMICS study aims to discover if, compared to CECC, using a MiECC system during cardiac surgery reduces the proportion of patients having one of several serious post-operative complications up to 30 days after surgery, as well as potentially reducing the amount of blood products transfused, time to discharge from the cardiac intensive care unit and hospital.

April 2018

The 4th edition of the VICI Trial newsletter has been published – Click here to see the latest news and final recruitment figures.

March 2018

March has been a very successful month for the CTEU, with a number of studies exceeding their recruitment targets, and the By-Band-Sleeve study has recruited it's 1,000th patient! 

February 2018

Along with our sister unit, Bristol Randomised Trials Collaboration, we will be receiving NIHR CTU Support Funding, to further support and collaborate on NIHR research applications and projects. You can read more about this support funding here. 

A study carried out at the CTEU into the effectiveness and cost-effectiveness of serum B-type natriuretic peptide testing and monitoring in patients with heart failure in primary and secondary care (MONITOR) was recently chosen as an NIHR Signal. These are are accessible, actionable summaries of recent, important health research, and MONITOR was chosen to be summarised as a Signal for its high-quality design and relevance to UK decision makers, amongst other criteria. You can read the Signal here:

January 2018

The Bluebelle study was the first study to explore the important issues related to the practical management of primary surgical wounds and patient experience immediately following surgery. A qualitative paper has just been published, which you can read here: 'Developing outcome measures assessing wound management and patient experience: a mixed methods study'  


At the recent official opening of Specialist Research Institute: Bristol Heart Institute, a CTEU poster won third prize. The poster was titled "The accuracy of near-patient haemostasistests for predicting bleeding after cardiac surgery", and displayed the results of the COPTIC study. This study was a large prospective cohort study designed to estimate how well a comprehensive panel of near-patient platelet function and viscoelastometry tests can predict subsequent clinical concern about bleeding (CCB). The findings suggest that the near-patient haemostasis blood tests performed immediately after cardiac surgery do not predict CCB better than baseline patient characteristics alone.

December 2017

The latest version of the CTEU newsletter has been published! Follow this link for updates on new studies and recruitment within the CTEU, as well as Patient and Public Involvement work and the results of the Thermic 2 study. 

The 900th patient has been randomised to the By-Band-Sleeve study by the Sunderland site. The By-Band-Sleeve study is aiming to compare the three different types of operations to find out which is most effective. The results of this study will be used to improve the information available to people considering bariatric surgery in the future, which will help with decision-making between health professionals and patients. The results will also be used to inform NHS commissioners about the most effective and cost-effective operation.

Dr Lucy Culliford, Research Fellow, presented at the Univeristy Hospitals Bristol Research and Innovation Showcase on the CTEU's use of SWATs (study within a trial). SWATs are used to answer questions in research such as which information leaflet works best for patient engagement, and Lucy's session was well received by those who attended. 

October 2017

A team from the Bristol Heart Institute, led by Professor Madeddu, have won the Research Impact Award at the Bristol Post Health and Care Awards 2017. This award celebrates research which will make a real difference to people's lives, and was awarded for the teams research into heart attack tissue damage, and how new cells around blood vessels are stimulated.  

The team involved in the Paediatric Cortisol (Peacock) study have recruited their first patients to the study. This is the first study of its kind looking at the cortisol levels in children under going cardiac surgery. It is possible by using a micro dialysis system developed here in Bristol by Stafford Lightman and his team. Recruiting these patients is testament to research being a team game! It would be impossible without the research nurses, trial co-ordinators, lab technicians, surgeons in and theatre and the doctors and staff in PICU.

If you would like more information about the study or you have a child coming in for cardiac surgery. Please contact email

September 2017

You can read all the latest PPI news from Bristol in the latest PPI Newsletter 

August 2017

The results of the SCAT trial have been mentioned in the Royal College of Surgeons' 'Cardiothoracic Surgery Update for August'. An online version of this update can be found here and the full article can be read here

Staff at the CTEU are very pleased to have our UKCRC Trials Unit Registration renewed for a further 5 years. Further information on the renewal can be found on the UKCRC website - 

July 2017

On the 21st July, University Hospitals Bristol hosted the British Heart Foundation South West Supporters Day. This event provided an opportunity for local BHF supporters to meet, and learn more about the research that takes place. Staff members from the CTEU presented a number of research posters during a 'science up close' section of the day. 

June 2017

Dr Rachel Brierley recently hosted a webinar entitled 'Methods to manage the randomisation and treatment of patients 24/7 in a large multi-centre RCT' as part of the HTMR Trial Conduct Working Group Webinars 2016-2017. If you would like to watch a recording of the webinar, it is available here: 

May 2017

IVAN Follow Up Success!

IVAN Follow Up has had a fantastic response from surviving participants of the original IVAN study. Given that the participants are visually impaired and elderly (average age is 85 years old) 363/413 participants who were sent an information pack returned the reply slip indicating how they wanted to participate in the study. 
There was also a very good response to the questionnaires that were posted out.

International Clinical Trials Day 2017

The CTEU held a number of events for International Clinical Trials Day 2017, including a stand in Paediatric Outpatients in the Bristol Children’s Hospital, demonstrating PPI work and showcasing current paediatric research studies. 

There was also a stand led by Research Nurses in the BHI Atrium, which had 3D heart models as well as study posters.

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PPI Team on International Clincal Trials Day         3D Printed Replicas of Hearts

CTEU Newsletter - Spring/Summer Edition 

The latest CTEU Newsletter is now available, with news and updates on studies within the unit. You can read it in full here. 

4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials

A number of CTEU staff members attended the ICTMC Conference in Liverpool at the beginning of May, and a number of abstracts were accepted as posters. 

  •          Use of instrumental variables within randomised controlled trials
  •          Does appearance matter? A study within a study
  •          Collecting trial quality data about complications routinely: a study within a study to maximize efficiency
  •          Concealing the randomised allocation in trials: experience from the Thermic trials
  •          Improving data quality through routine automated reporting using standard statistical software
  •          Analysis challenges in Blood Stream Infection: Focus on outcomes study
  •          Challenges in the analysis of a randomised controlled trial with retrospective consenting: the RAPIDO study
  •          Variability in composite outcomes reported in cardiac surgery studies: a literature review
  •          Patterns of adverse events after cardiac surgery
  •          Development and First Evaluation of the ATLAS Training Toolkit for Clinical Trials. 

The full abstracts from the posters can be read here.

South West South Wales CHD Network 

The South West South Wales CHD (Congential Heart Disease) Network was formed in April 2016 in order to bring together health professionals, patients and families involved with congenital heart disease services. The network is producing a quarterly newsletter, and included in the first edition there is a profile of the Paediatric Cardiac Research Team.

'Since 2011 there has been a cardiac research nurse working at the Bristol Children’s Hospital. The idea was to capture all research activity involving cardiac patients to ensure a unified approach.

Today there is one full time Research Sister and 4 part time Senior Research Nurses. We cover both Cardiology and Cardiac Surgery studies. We work collaboratively with all clinical areas and clinicians to provide best practice in any re-search study involving cardiac patients. Our role is to screen for patients who may be eligible for a study, give them information about the study in a way they can under-stand, and consent them to the trial if they feel it is right for them. We also collect data, organise appointments and tests and many more tasks we won’t bore you with. Our main role though as we see it is to give our patients and families a good experience of being ap-proached for research, whether they take part or not. We always say that it’s our job to give information and answer questions so that the family can make the deci-sion that’s right for them.'

The paediatric cardiac research team currently has 12 studies in different stages of set up, recruitment, follow up and close down. Our studies which are currently recruiting are:

  • INCIDENCE/IMPACT study which looks at complications after cardiac surgery in children and how those complications impact on the child and family after discharge from hospital.
  • INVITE which looks at standard surgical replacement of Pulmonary valves versus injectable valves in teenagers and adults.
    RVENCH which is aiming to understand why some patients tolerate high right ventricle pressures and some don’t.
  • STEM CELL which is developing techniques to be able to grow a patient’s own tissue for use in cardiac surgery in the future.

They are also in the follow up stage for a national drugs trial looking at aortic root growth in Marfan’s patients. It is one of 10 international studies looking at this issue and Bristol was the highest recruiter for the study thanks to the generosity of our patients.

Studies cover all surgical patients coming to Bristol Children’s Hospital from all over the South West and Wales. The research team are also heavily involved in developing PPI (public & patient involvement) in research. This means anything from helping decide what areas of practice need to be looked at in research, to helping design information, giving feedback on research protocols and study design. They are working with Noreen Hopewell-Kelly to set up patient and parent groups to help take this forward. They recently held a competition at a Bristol primary school to design a logo for all our young person’s paperwork and website. This is just a start and they have invited families around the South West and Wales to get involved. 

For more information please contact the team on 0117 342 8889

You can read the first newsletter in full here

April 2017

A £21 million National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) in Bristol will launch this week [1 April]. The research centre, awarded to University Hospitals Bristol NHS Foundation Trust (UH Bristol) and the University of Bristol by the NIHR, will conduct cutting-edge research to develop new, ground-breaking treatments, diagnostics, prevention and care for patients in a wide range of diseases. You can read more here:

February 2017

Recruitment target reached for VEST III, with a brilliant message from the Industry sponsor:

‘Great work Bristol team! We really appreciate your hard work, serious attitude, and unprecedented attention to detail! It is a pleasure  to work with you!’

 Well done to the nursing team for this achievement!


Autumn/Winter CTEU Newsletter

Read an update on recent research studies taking place within the CTEU - 2016 Autumn/Winter Newsletter

October 2016

IVAN Follow Up Study

Since the first site opened for the IVAN Follow Up study in May, another 15 sites have been opened across the UK!

Read more about what the study is hoping to find out here: 

Feel It Festival 

'It’s Just a Pain' explores the journey of a young patient with congenital heart disease. Large panels show outlines of hearts intertwined with the language that accompanies the journey’s phases: anatomy, conditions, medications, techniques and devices, and narrative. The installation also includes 3D printed models and the opportunity to listen to a six minute soundscape created as part of the project. During the festival, there will be an opportunity to take part in an embossing workshop with artist Sofie Layton. Collaborator Giovanni Biglino (Bristol Heart Institute) will be present to discuss the artist/scientist collaboration. On the festival’s opening night they will be joined by Massimo Caputo, Professor of Congenital Cardiac Surgery at the Bristol Heart Institute, to talk about the work.

Opening times: Saturday 19 November, 10:00 - 15:00 Sunday 20 November, 13:00 - 14:30 Tickets: No tickets required Venue: Circomedia, Portland Square Price: Free Website: (artist) To attend the opening night, which includes a dialogue with the installation creators, a ticket is needed:

Collaboration with Manchester United 

The Manchester United and Toshiba collaboration with NIHR Bristol Cardiovascular BRU is now an international collaboration, with the research project being run over three weeks at the Aspire Academy in Doha Qatar!

Research in Bristol boosted by £21 million award over five years

University Hospitals Bristol NHS Foundation Trust (UH Bristol) in partnership with the University of Bristol has been awarded more than £20 million over five years by the National Institute for Health Research (NIHR) to fund cutting-edge research. The CTEU is linked with the Cardiovascular theme of this award, and are very excited at the oppurtunity this presents. 

July 2016

ECHoES Study Published

The ECHoES study aimed to determine whether follow up by optometrists in optician practices in the community is as good as follow-up by opthalmologists.  Rather than carrying out a new trial, eye images (colour fundus and ocular coherence tomography images) collected during a large UK based multicentre clinical trial (the IVAN trial) were used to determine whether optometrists can detect disease activity and make the same decisions about re-treatment as opthalmologists. 

The NIHR have created a summary which can be read here: and the full paper accessed via this link:

IVAN Follow Up Study 

5 year observational follow-up of the IVAN trial cohort opens 8 sites within three months!

June 2016

By-Band-Sleeve reaches another milestone

The By-Band-Sleeve study has recently randomised its 450th participant!

This is a great achievement for all involved in the study.

A full summary of the study can be found on the Studies section on our website.

The Clinical Trials and Evaluation Unit welcome two new members of staff

Dawn Phillips and Maddie Clout have recently joined the CTEU coordination team, as Clinical Trial Coordinators.

We are pleased to have them on-board!

May 2016

Podcast on Clinical Trials Units

Prof Julia Brown, Director of the UKCRC Reg CTUs Network features on a podcast on the value of Clinical Trials Units for the Cochrane Collaboration


InVITe study opens to recruitment

InVITe will investigate the effectiveness of injectable pulmonary valve replacement compared to standard pulmonary valve replacement. Patients will be allocated at random to receive either the “injectable” valve or standard valve.

The study will follow patients to determine whether the use of injectable valves results in quicker recovery and shorter stay in hospital and is cost saving for the NHS. It will also determine whether the valves function as well as the conventional ones.

Further information about InVITE can be found on the study summary page. 

March 2016

The role of Clinical Trials Units in developing an NIHR funding application - New NIHR video

The National Institute for Health Research (NIHR) have recently released a video highlighting the part that Clinical Trials Units (CTUs) play in developing an NIHR funding application.

The video outlines both the role of CTUs and the benefits of working with them.

To find out more, and to watch the video, please click on the following link: NIHR Newsroom.


ProMPT results shared with study participants

Following the publication of results in December 2015, all patients who participated in the ProMPT study have received a leaflet summarising the results in plain English.

The study: During cardiac surgery a heart-stopping solution is injected into the heart which allows the surgeon to operate whilst the heart is still and free of blood. The study assessed whether adding propofol to the heart-stopping solution protected the heart during cardiac surgery. Previous research suggested that the anaesthetic ‘propofol’ could protect the heart.

Between February 2010 and October 2012, 101 patients gave their consent to take part in the study. These patients had either propofol or a placebo added to their heart-stopping solution.

The results suggest that addition of propofol to the heart-stopping solution does protect the heart from damage during cardiac surgery. The protective effect of propofol may be different depending on the operation; it seems to be more beneficial for CABG surgery than for AVR surgery, however, it is not clear why this is the case.

The results are very useful and more research is planned to make firm recommendations for future patients having cardiac surgery. The results of ProMPT were published in December 2015 in The Journal of Thoracic and Cardiovascular Surgery.

This work was supported by the NIHR Bristol Cardiovascular Biomedical Research Unit. The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the National Institute for Health Research, or the Department of Health.


Best poster prize for AIRWAYS-2

Two posters describing the AIRWAYS-2 trial (which is coordinated by the CTEU) were submitted to the 999 EMS research forum earlier this month.

The poster, AIRWAYS-2: Overcoming the challenges of setting-up a large and complex pre-hospital trial won best poster prize.

The 999 EMS Research Forum aims to encourage, promote and disseminate research and evidence-based policy and practice in 999 health-care. 


December 2015

By-Band-Sleeve study featured in new campaign

The By-Band-Sleeve study, which is being coordinated by the CTEU, has been featured in a campaign by the National Institute for Health Research (NIHR) on obesity research. 

By-Band-Sleeve is one of four studies chosen to promote ‘The BIG Challenge’ campaign.

Further information can also be found on the University of Bristol website.

To find out more about the study, visit the By-Band-Sleeve study website.


HTA Director acknowledges IVAN study in departing message

Professor Tom Walley, exiting Director of the NIHR HTA Programme, has acknowledged the success of the IVAN study in his reflections on leaving the HTA

The CTEU was the trial coordinating centre for the IVAN study, which showed that bevacizumab was as effective as more expensive drugs for the treatment of wet age-related macular degeneration.

The full article can be read here:

August 2015

By-Band study moves to By-Band-Sleeve!

The CTEU is the co-ordinating centre for the NIHR-HTA funded multi-centre randomised study, By-Band, which aims to establish whether gastric bypass surgery for severe and complex obesity leads to better quality of life and as good weight loss as gastric band surgery at three years.  

Earlier in 2015 the NIHR-HTA awarded further funding to adapt By-Band to By-Band-Sleeve and the By-Band-Sleeve study has now opened to recruitment. This revised design includes a third procedure sleeve gastrectomy and will allow three comparisons to be made:

-          Gastric bypass vs. gastric band

-          Gastric bypass vs. sleeve gastrectomy

-          Gastric band vs. sleeve gastrectomy

Eligible patients who agree to take part will now be allocated to gastric bypass, gastric band, or sleeve gastrectomy. The study will run in 12 UK centres and over the next four years. The aim is to recruit a total of 1341 participants.

For further information on the By-Band-Sleeve study please visit:

March 2015

Main TITRe2 findings sent to patients! 

The TITRe2 team has published a leaflet summarising the results of the study in plain English. This leaflet has been sent to patients who took part in the study to coincide with publication of the findings of the TITRe2 trial. TITRe2 enrolled over 3,500 patients having heart surgery from 17 hospitals across the UK, making it the largest ever cardiac surgery trial in the UK. The study was carried out between July 2009 and October 2014.

Before the study started there was no clear evidence about when patients should have blood transfusions after heart surgery. At that time, about 4 of every 10 patients were given a blood transfusion but this number varied a lot across the UK. Usually, a haemoglobin measurement (a simple blood test) is used as a guide, but different hospitals and different surgeons were giving blood transfusions at different haemoglobin levels. This variation showed that doctors were uncertain about when to give a blood transfusion. To resolve the uncertainty, the study aimed to compare the proportion of patients having complications after surgery when given blood at a low haemoglobin level with the proportion having complications when given blood at a high haemoglobin level.

The results of TITRe2 were published on 12th March in the New England Journal of Medicine. The team want to mark this occasion by saying a big thank you to patients who took part in the study. Without the selfless willingness of patients to take part, there would have been no study. Further information about the TITRe2 research study and its results can be found on the TITRe2 patient leaflet and on the University of Bristol’s press release.

The TITRe2 trial was funded by the UK National Institute for Health Research, part of the NHS. The above views and opinions about the findings are those of the TITRe2 team and do not necessarily reflect those of the NIHR, the UK NHS or the Department of Health.

February 2015

Beat it, Wear it– 6th February 2015

On the 6th February the CTEU joined in with the ‘Beat it Wear it’ campaign organised by the British Heart Foundation as a way for people to show their support for the BHF by wearing red and hosting an event to help fund BHF research. On the day several British Heart Foundation supporters also visited the CTEU to learn more about the research being conducted by the unit. A total of £165 was raised and as you can see from the photo below we had a great turn out on our floor, and would like to thank everyone who got involved!

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January 2015

Paper published: Systemic safety of anti-VEGF drugs: a commentary

A paper titled ‘Systemic safety of anti-VEGF drugs: a commentary’ was published recently with the involvement of the Clinical Trials and Evaluation Unit’s statistician Lauren Scott and co-directors Chris Rogers and Barney Reeves. VEGF inhibitors, such as ranibizumab and bevacizumab, are commonly used in the treatment of neovascular age-related macular degeneration (nAMD). However, safety concerns have been raised about these interventions. The authors conducted a non-systematic review of nAMD trials looking at four safety outcomes; all-cause mortaility, all systemic serious adverse events (SSAEs), arteriothrombotic events (ATEs) and gastrointestinal (GI) complications. Event rates were compared for a number of anti-VEGF agents. Analyses showed that anti VEGF agents can influence vascular health; however, the data suggest no difference in the risk of an ATE or death between anti-VEGF agents. 


November 2014

The Preconditioning study has completed recruitment 

The Bristol Heart Institute is a participating site in the Preconditioning study, which is being coordinated by the Hammersmith Hospital in London.  The study has been recruiting since October 2012 and has recently completed recruitment. In total 120 patients were recruited with 43 of these being recruited at the Bristol Heart Institute. 

The purpose of the study is to monitor the changes in the heart that are caused by remote ischaemic conditioning (RIPC). RIPC is the process of conditioning (preparing) the heart for damage that can sometimes occur during heart surgery.  RIPC is performed by inflating and deflating a blood pressure cuff on a patient’s upper arm prior to surgery.  The inflated blood pressure cuff restricts blood flow to the muscles of the arm causing lack of oxygen (ischaemia).  Some studies have shown that this can have a protective effect on the heart during cardiac surgery. 

We hope that the results of this study will improve our knowledge of the mechanisms involved in RIPC and help establish whether there are benefits from RIPC on a cellular level.  The researchers involved in the study will now begin the process of analysing and interpreting the data before the results are ready for publishing. 

Excellent recruitment by the two new By-Band sites

Currently, the By-Band study, which up to recently has been open in two sites in Taunton and Southampton, is moving into phase II which involves opening six additional centres.  So far two new sites (Royal Bournemouth Hospital and St James University Hospital, Leeds) have officially opened and begun recruitment. The By-Band team at Bournemouth and Leeds have performed brilliantly since opening for recruitment, randomising a total of 3 and 4 patients respectively.  These excellent recruitment figures demonstrate the hard work and dedication to the study shown by the new centres and within the CTEU.

The By-Band study aims to find out the best and most cost effective operation to treat complex severe obesity.  There are two main types of operation that are currently used in hospitals across the UK: Gastric Bypass and Gastric Band.  The study aims to compare these two types of operation to see which one is better.  The study is spilt into two phases. Phase I took place in two centres: Musgrove Park Hospital Taunton and University Hospital Southampton to establish the feasibility of the study and a progression criterion was set to inform whether the study would extend to more centres. The progression criterion was met and the Trial Steering Committee along with the funder (NIHR-HTA) agreed that the study could proceed to phase II.  Phase II aims to recruit the full sample of 724 patients across a total of 8 hospital sites.  The study is measuring weight loss, a range of symptoms and the patients’ quality of life for up to 3 years after surgery.  The patients’ experience during follow up, nutritional outcomes, surgical outcomes and NHS value for money will also be examined.

To read more about the By-Band study, visit the website on:

October 2014

TiTRe2 study results presented at the European Society of Intensive Care Medicine (ESICM) conference in Barcelona (29th September 2014) and at the 28th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Milan (13th October 2014)

In the TiTRe2 study patients were allocated by chance to have decisions about whether blood transfusions after heart surgery were given or not, made either according to current practise, or only when the haemoglobin (Hb) level drops to a lower “restrictive” level.  The aim was to determine whether the “restrictive” level safely reduces the number of transfusions given by decreasing the number of infectious and other complications (stroke, heart attack or kidney failure) that occur during the first three months after surgery.  This is an important topic as unnecessary blood transfusions increase healthcare costs both directly, because blood is an increasingly scarce and expensive resource, and indirectly, due to complications associated with transfusion.  The TITRe2 team have finished recruitment and are in the process of writing the final study report.  The study results have been presented and well received at two recent European conferences by our CTEU co-directors Barney Reeves and Chris Rogers.

September 2014

Cochrane review published on the systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration

The Cochrane review on the systemic safety of bevacizumab versus ranibizumab for neovascular age-related macular degeneration (AMD) was published recently with the involvement of the Clinical Trials and Evaluation Unit’s co-directors Chris Rogers and Barney Reeves. Neovascular AMD is a progressive and chronic disease of the eye, and is a leading cause of severe blindness in elderly populations.  The review focuses on evaluating if the two drugs differ in terms of deaths or in patients’ health during follow up of a maximum of two years.  The review included nine randomised controlled trials (RCTs) with 3665 participants directly comparing bevacizumab with ranibizumab.  Analyses showed the systemic safety of bevacizumab for neovascular AMD to be similar to that of ranibizumab, except for gastrointestinal disorders, which were more common with bevacizumab.

Excellent recruitment for Decision

In September the Decision study (Detection of Coagulopathy in Paediatric Heart Surgery) had excellent recruitment, 17 patients consented to take part.  This achievement involves a great deal of work by the staff within the Clinical Trials and Evaluation team and brings the study closer to its recruitment target. 

August 2014

New study looks at the role of wound dressings in preventing infection

Researchers from the Universities of Bristol and Birmingham have received funding from the UK National Institute for Health Research (NIHR) for the Bluebelle Study looking at the role of wound dressings in preventing infection.  A wide variety of wound dressings are currently available and whilst the application of wound dressings is standard practise following surgery in adults, wound dressings are rarely applied after surgery in children.  A scientific review has also found no evidence to suggest that applying wound dressings reduces the risk of wound infection, or that any particular wound dressing is more effective than another.  Researchers will design a pilot randomised control trial and will compare the effectiveness of wound dressing types in general and obstetric surgery. Professor Jane Blazeby, from the School of Social and Community Medicine at the University of Bristol will lead the research and the Clinical Trials and Evaluation team will be responsible for the co-ordination of the study.  Please visit our ‘Studies’ page to learn more about the Bluebelle study and other trials that are currently running.

July 2014

The Clinical Trials and Evaluation Unit welcome three new members of staff

Three new members of staff have recently joined the Clinical Trials and Evaluation Unit (CTEU). Jennifer Heath has joined as a Clinical Research Administrator; Pippa Brakespear-Dean has taken on the role of BRU Office Manager and Jonathan Betts has joined the database team as a Database Manager.

The ProMPT trial protocol paper has been published

During cardiac surgery the heart is isolated from the rest of the circulation using a heart-lung machine.  A heart stopping solution (cardioplegia) is injected through the arteries into the heart and the heart lung machine is used to oxygenate and pump blood around the rest of the body.  During the operation the heart muscle can become short of oxygen and when the blood is allowed to flow through again, damage can occur.

Recent research suggests that a general anaesthetic (propofol) that is used widely in cardiac surgery could protect the heart muscle against damage that occurs during this period of low oxygen and when blood flows back through the heart.  In the ProMPT study they are assessing whether adding propofol to the cardioplegia (heart stopping) solution helps to protect the heart muscles of cardiac patients. A total of 96 patients have been successfully recruited over a 2 year period to this trial and results are to be published in late 2014.  The CTEU staff working on this trial have successfully published the ProMPT protocol paper which provides further detail about the trial and the methods used.  This can be accessed through the following link:

The VeRDICT trial recruits its final patient!

The VeDICT trial started recruitment in July 2010 and recruited the final patient in July 2014; recruiting in total 170 patients.  The VeDICT trial aims to find out whether giving fluid intravenously by a ‘drip’ before coronary artery bypass (CABG) operation (pre-operative volume replacement therapy) improves the speed of recovery and rate of complications in diabetic patients compared to patients that do not have a’drip’ before their CABG operation.  This is an important comparison to make in diabetic patients as these patients have a higher risk of kidney problems after a CABG than if they were non diabetic.  The team working on the VeDICT trial will now start analysis of data and we will provide an update on the website when the results are published.

June 2014

The TITRe2 trial protocol paper has been published!

In June 2014 the TITRe2 team published its protocol paper in the Journal Transfusion and Apheresis Science.  TITRe2 was carried out in a number of UK hospitals looking at the haemoglobin levels used to inform doctors decisions to give a blood transfusion. This is an important topic as unnecessary blood transfusions increase healthcare costs both directly, because blood is an increasingly scarce and expensive resource, and indirectly, due to complications associated with transfusion.  In the trial patients whose Hb levels drop below the level at which the transfusion is conventionally given were assigned by chance to have the decision to transfuse made on (a) more or less as they are now, or (b) only when the Hb level drops to a lower, ‘restrictive’ level.  The primary outcome was the number of infectious (sepsis) and ischaemic (stroke, heart attack or kidney failure) complications that occurred during the first 3 months of surgery.  The protocol paper is available to view here:

May 2014

The By-Band study launches their new website!

The By-Band study aims to find out the best and most cost effective operation to treat complex severe obesity.  There are two main types of operation that are currently used in hospitals across the UK: gastric bypass and gastric band.  The study aims to compare these two types of operation to see which one is better. The By-Band study has launched its own website containing further information about the study.  This is an exciting new development for the study because patients taking part in the By-Band study will now have the option to complete follow up questionnaires online in addition to the postal questionnaires that are currently in use.  Please visit the website at and have a browse!

April 2014

The By-Band study moves into Phase II of recruitment

The By-Band study has recently begun Phase II expanding recruitment into 5 additional hospitals across England.  The new centres to become involved are: Sunderland Royal Hospital; Luton and Dunstable Hospital; Royal Bournemouth and Christchurch Hospital; Leeds General Infirmary and Homerton University Hospital.  The By-Band study is a pragmatic randomised controlled trial (RCT) with two phases.  Phase I took place in two centres; Musgrove Park Hospital and University Hospital Southampton to establish the feasibility of the study and a progression criterion was set to inform whether the study would extend to more centres.  The progression criterion was met and the Trial Steering Committee (TSC) along with the funder (NIHR-HTA) agreed that the study could proceed to phase II.  In phase II the By-Band study has begun extending into additional hospitals and are aiming to recruit 614 patients in total and will be following patients up for 3 years.  To find out more about the By-Band study visit the website at

The EVARREST trial has recruited its first patient

During cardiac surgery occasionally bleeding will occur that the surgeon has to control.  There are various ways this can be done, but we want to find out how a new product for stopping bleeding (EVARREST) compares against another commonly used product (Tachosil).  The Clinical Trials and Evaluation Unit has started recruiting patients for this study and along with other centres in Europe, Australia, New Zealand, Japan and the United States aims to recruit between 150 and 210 patients.  The EVARREST team successfully recruited the first patient last week within 21 days of receiving local research and development approval.  This is well within the national 70 day target set out by the Department of Health. A great effort by all involved!

March 2014

Bristol Surgical Trials Centre Launch Event

This launch event was a great opportunity to hear about the new Bristol Surgical Trials Centre (BSTC).  The new BSTC is a multi-disciplinary collaboration aiming to transform patient care by increasing evidence based surgery.  The centre is led by Jane Blazeby, Professor of Surgery at the University of Bristol, in collaboration with the CTEU co-director Dr Chris Rogers and Alan Montgomery (Senior Statistician), Gianni Angelini (Professor of Cardiac Surgery) and Ashley Blom (Professor of Orthopaedic Surgery).

The launch event was held at the Mshed, Bristol on Friday 28th March 2014, and included an opportunity for attendees to pitch trial ideas in a Dragons’ Den style presentation to top UK researchers. The winner received the dragons’ full support and resources to make their trial a reality.