International Clinical Trials Day 2017
The CTEU held a number of events for International Clinical Trials Day 2017, including a stand in Paediatric Outpatients 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.
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.
South West South Wales CHD Network
The South West South Wales CHD 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.'
There is also a summary included decscribing the studies that the team are involved in
'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.
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: http://www.bristol.ac.uk/news/2017/march/biomedical-centre.html
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
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: http://cteu.bris.ac.uk/our-trials/?trialType=Ophthalmology#3813
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: www.sofielayton.co.uk (artist) To attend the opening night, which includes a dialogue with the installation creators, a ticket is needed: www.bristol.ac.uk/feel-it-festival
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.
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: http://www.nets.nihr.ac.uk/news/all/2016/routine-monitoring-of-eye-condition-effective-in-the-community and the full paper accessed via this link: http://bmjopen.bmj.com/content/6/7/e010685.full
IVAN Follow Up Study
5 year observational follow-up of the IVAN trial cohort opens 8 sites within three months!
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!
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.
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.
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: http://bit.ly/1RdTrqq
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: http://www.by-band-sleeve.bris.ac.uk/
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.
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!
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.
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: http://www.by-band.bris.ac.uk/
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.
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.
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.
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: http://www.ncbi.nlm.nih.gov/pubmed/25004932.
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.
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: http://www.sciencedirect.com/science/article/pii/S1473050214000652
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 http://www.by-band.bris.ac.uk and have a browse!
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 http://www.by-band.bris.ac.uk.
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!
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.