Comprehensive ascertainment of bleeding in patients prescribed different combinations of dual antiplatelet therapy (DAPT) and triple therapy (TT, DAPT plus an anticoagulant) after coronary interventions in the UK: a population based cohort study

Funder: NIHR/HTA (project number 14/192/89)

Sponsor: University Hospitals Bristol

Status: Ongoing

Antiplatelet drugs are used to prevent heart disease and stroke. They work by preventing the formation of blood clots in arteries.

In people who have had a heart attack or have diseased arteries, low-dose aspirin (75 mg daily) is recommended to prevent another heart attack or a stroke. People who have had a coronary stent or coronary artery bypass grafting (CABG) surgery following a heart attack are prescribed low-dose aspirin and an additional antiplatelet drug, for up to 12 months following the event. This is called dual antiplatelet therapy (DAPT). Furthermore, some patients (e.g. those with atrial fibrillation) are also prescribed an anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, or apixaban) in addition to DAPT, which is known as ‘Triple Therapy’.

Antiplatelet therapies increase the risk of bleeding, from minor bruising to more severe symptoms such as gastrointestinal bleeding. Few studies have assessed how often bleeding events happen in people taking DAPT. Hospital doctors are increasingly prescribing more antiplatelet therapy to people who have had a stent or CABG surgery, without taking into account the risk of minor bleeding. The extent of minor bleeding and the effect that it has on patients is not known because most minor bleeding events are treated by GPs and patients do not go to hospital.

The ADAPTT study will use a large GP database of routinely collected data, and a database of patients’ attendances and admissions to hospital, to determine how many people experience bleeding after being prescribed DAPT or DAPT and an anticoagulant. We will compare patients who take aspirin only with patients taking different combinations of DAPT (with or without an anticoagulant).

We will do this for different patient groups (treated with stent, CABG surgery or medication only) and will look into the cost-effectiveness of DAPT. We will also review the literature to determine how bleeding affects quality of life in these individuals. Information from the ADAPTT study will help doctors to choose drugs that are more appropriate for individual patients’ specific needs, which will reduce the risk of bleeding and increase adherence to treatment.

 

Contact Information

Chief Investigator: Dr Maria Pufulete, Research Fellow

E-mail: adaptt-study@bristol.ac.uk

 

Association of non-coding RNAs with Coronary Artery Disease and type 2 Diabetes

Status: In Follow Up 

Sponsor: University Hospitals Bristol 

REC Number: 13/LO/1687

Genes hold the information to build and maintain the human body.  They contain the code to produce proteins which perform many functions within our body.  However, genes do not do this alone and instead rely on the help of other molecules.  Recently, scientists have discovered the existence of chemicals called “non-coding” ribonucleic acids (ncRNAs).  These chemicals may influence the production of proteins and have an important role in the heart; some of them can aggravate heart conditions while others can have positive effects. The levels of these chemicals, which are present in the tissues and fluid of the body, may be possible indicators of disease or of the effects of heart surgery.

In Arcadia we are asking participants who undergo cardiac surgery to provide heart biopsies and blood and urine samples, and allow us to use tissue samples left over from surgery.  We are measuring and identifying all non-coding RNAs in these tissues and determining whether their levels are affected by heart disease and diabetes. The study also aims to find out whether we can measure the ncRNAs in blood, urine and tissue of patients undergoing heart surgery, to predict which patients will develop complications.  This study is important because it could help identify treatments to improve the recovery of the patients after heart surgery.

If you have taken part in the ARCADIA study and you are interested in how we use your data, please see our Privacy Statement.

Contact Information

Chief Investigator: Prof. Gianni Angelini

Study coordinatorRachael Heys (Bristol Royal Infirmary), Alima Rahman (Hammersmith Hospital)

E-mailarcadia-study@bristol.ac.uk

 

Investigation of neural mechanisms of COgnitive DEcline after Cardiac surgery with resting state fMRI: A Pilot study (The CODEC study)

Funder: Above and Beyond Grant

Sponsor: University Hospitals Bristol  

IRAS number: 247211

Status: In set up

Cognitive impairment is common after cardiac surgery, particularly in older people. Up to six in every 10 patients who undergo cardiac surgery have some degree of cognitive impairment six months after their surgery. The mechanisms involved are unclear. Recent research in brain imaging has identified some regions of the brain involved in learning and memory which are working when the brain is “at rest”, that is when the subject is not performing an explicit cognitive task. These brain networks, so called “resting state networks”, represent the baseline, or default, mode of the brain. Brain imaging studies have shown that when the activity of resting state networks is reduced, patients are more likely to develop cognitive impairment. There is currently limited evidence to suggest whether cardiac surgery causes damage to resting state networks thus leading to cognitive impairment. The CODEC study will investigate change in resting state networks in 20 patients undergoing cardiac surgery with cardiopulmonary bypass using functional brain magnetic resonance imaging (fMRI). It will also look at whether changes in these networks correlate with changes in cognitive function.

Patients who consent will be required to undergo two fMRI scans and neuro-cognitive assessments. The neuro-cognitive tests will assess memory, co-ordination and levels of attention. Patients will have the first scan and neuro-cognitive assessments pre-surgery and the second scan and assessments will take place post-surgery (approximately 6 weeks post surgery). We will also collect information on clinical outcomes after surgery.

Contact Information

Chief Investigator: Mr Umberto Benedetto

Senior Research Fellow: Dr Maria Pufulete

Study coordinator: Lucy Ellis

E-mailcodec-study@bristol.ac.uk

 

Conventional versus Minimally Invasive extra-corporeal circulation in patients undergoing Cardiac Surgery: a randomised controlled trial (COMICS)

Status: Recruiting

During many types of heart surgery, the blood, which would normally pass through your heart, is passed through a heart-lung machine. The heart-lung machine does the work of the heart and lungs by keeping the blood oxygenated and flowing around your body, whilst the heart is stopped and lungs are deflated. This machine makes it easier for the surgeon to operate because the heart and lungs are not moving and there is no blood in the heart. However, using the heart-lung machine increases the chances of having a complication after surgery. These complications can impede recovery and increase the length of hospital stay.

The purpose of the COMICS study is to compare the use of conventional heart-lung machines with miniaturised heart-lung machines. Miniaturised heart-lung machines have been developed by several manufacturers with the aim of reducing the risk of having a complication due to from using a heart-lung machine. 

This study will compare the incidence of a number of specified complications in patients having their operation with using the conventional heart and lung machine and patients having their operation using the miniaturised heart and lung machine. The complications that the miniaturised heart-lung machine aims to avoid include heart attack, stroke, major bleeding and blood transfusion, and kidney injury. The study will also look at the amount of blood products transfused in both groups, the length of hospital stay and the overall resources used to treat patients during their hospital stay.

Funder acknowledgement: BHF, NIHR Bristol Biomedical Research Centre

IRAS Number: 222991

ISRCTN: 92590475

 

 

Contact Information

Chief Investigator: Professor Gianni Angelini

Trial Coordinator: Jonathan Evans

E-mail: comics-trial@bristol.ac.uk

 

Ultradian rhythms of cortisol after cardiac surgery

Sponsor: University of Bristol

REC Number: 11/H0107/9

Status: Closed to recruitment

Heart surgery provokes a large stress response in the body, which can lead to complications after surgery.  Cortisol is the main hormone responsible for the stress response, but currently researchers do not know how heart surgery affects cortisol production and whether steroids can be given in a more tailored way. 

The Cortisol study is examining whether heart surgery disrupts the diurnal rhythm of cortisol production, which normally causes cortisol to increase early in the morning and dip by late afternoon.  This rhythm is produced by discreet pulses and researchers believe that disrupting these pulses increases the stress response after surgery. 

We are recruiting men undergoing a coronary artery bypass grafting (CABG) operation to investigate cortisol pulses after surgery.  Women are not being recruited due to the cyclical effects of female hormones on these rhythms. We are also investigating whether the use of the bypass machine during heart surgery influences cortisol production. For this initial part of the study, we allocated a group of similar patients by chance to receive surgery with a bypass machine or surgery without a bypass machine.  

Contact Information

Chief Investigator: Dr Ben Gibbison

Study coordinator: Jon Evans

E-mail: Cortisol-trial@bristol.ac.uk

 

Cortisol profiles in the critically ill after cardiac surgery

Sponsor: Bristol University 

REC Number: 12/SW/0186

Some patients do not recover well from cardiac surgery and become critically ill on life support machines.  One of the causes of this is an uncontrolled inflammatory response. The inflammatory response is what causes your sprained ankle or cut hand to become red and swollen. It gets red because the blood vessels get bigger and it gets swollen because fluid leaks out of the blood vessels and into the tissues. This is helpful if it is a small area, but when it is across the whole body, such as after cardiac surgery it can be problematic and potentially life-threatening.

We all produce a hormone called cortisol (a steroid) that helps protect against an uncontrolled inflammatory response. It is thought that there are some people who do not produce enough cortisol or do not produce it in the right pattern. Doctors often give synthetic cortisol type drugs (corticosteroids) to patients when they are critically ill to reduce this inflammatory response. However, if they are used in too large a dose, these drugs can have significant side effects such as immunosuppression, poor wound healing and a diabetic state. Cortisol is released in discreet pulses throughout the day, called an ultradian rhythm. 

The Cortisol 2 study is investigating what happens to these pulses of cortisol in people who are critically ill.  We are recruiting patients who have had cardiac surgery and go to the cardiac intensive care unit (CICU).  We are taking blood samples over 24 hours to measure cortisol and describe its ultradian rhythm.  Once we know what is ‘normal’ during critical illness, we can begin to design tests to see which patients might benefit from steroids and if so, give them in a more tailored way.

further details >

Contact Information

Chief Investigator: Prof Stafford Lightman

Study coordinator: Jon Evans

E-mailcortisol-trial@bristol.ac.uk

 

Effectiveness, cost effectiveness and safety of gabapentin versus placebo as an adjunct to multimodal pain regimens in surgical patients: A placebo controlled randomised controlled trial with blinding (The GAP study)

Funder: NIHR/HTA (17/YH/0381)

Sponsor: University Hospitals Bristol  

Status: Recruiting

About 4.5 million people undergo surgery each year in the UK. Most patients experience pain after surgery.  Good pain control is essential to recovery. Opioids (e.g. morphine) are typically prescribed to control the pain. Opioids are effective but carry side effects such as sleepiness, sickness and low blood pressure. These side effects 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 GAP study will recruit patients having heart, thoracic (e.g. lungs) or abdominal surgery. Patients who agree to participate will be allocated by chance to receive either gabapentin or identical-looking “dummy” pills (placebo) just before their operation and for two days following their operation. We will collect information on pain experienced after surgery, the amount of opioid medications used, any complications patients experience and how long patients stay in hospital. We will also collect information on quality of life and chronic pain experienced 4 months after surgery.

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.

GAP_PIL_v3.0_appendix

 

 

Contact Information

Chief Investigator: Dr Ben Gibbison 

Lead Applicant: Professor Chris Rogers

Study coordinator: Sarah Baos

E-mail: gap-study@bristol.ac.uk

 

A randomised controlled trial to assess the axtent of intimal Hyperplasia and Atherogenesis in bypass Vein grafts following different Surgical preparation Techniques

Sponsor: University Hospitals Bristol 

REC Number: 09/H0101/28

Status: Analysis

During coronary artery bypass grafting (CABG) surgery, vein grafts removed from other parts of the body are used to bypass diseased arteries in the heart and improve blood flow.  Vein grafts can become narrow over time and which increases the risk of having another heart attack.

Harvest is designed to test whether the method of surgical preparation of the vein grafts at the time of the operation decreases the risk of blockage one year after surgery.  Currently, vein grafts are prepared by stripping away the surrounding fat at the time the vein is removed from the leg.  The vein is then tested for leaks by filling the graft with fluid under high pressure, using a syringe.  It is thought that this method may damage the vein.  Other methods of preparation involve removing the vein from the leg with its surrounding fat and testing for leaks at lower pressure. 

Patients who consent to take part in Harvest are allocated by chance to different vein harvesting and vein preparation strategies and followed up for one year, when they will have detailed investigations of the vein grafts. 

A total of 97 patients have been successfully randomised over 3 years and 10 months and followed-up for 1 year. The trial is currently in analysis phase and results are expected to be published in summer 2017. 

Contact Information

Chief Investigator: Prof Gianni Angelini

E-mail: harvest-trial@bristol.ac.uk

 

 Effectiveness and cost-effectiveness of INSPIRatory musclE training (IMT) for reducing postoperative pulmonary complications (PPC): a sham-controlled randomised controlled trial (RCT): INSPIRE

After major operations, some patients develop complications of the lungs, including pneumonia. These complications can be serious. They may result in long stays in hospital, may prolong recovery from surgery and may reduce patients’ quality of life. Lung complications are common, affecting on average one in ten patients, with the risk for a particular individual depending on their current health and the type of surgery they are having.

The INSPIRE study is investigating whether a series of daily breathing exercises that aim to improve the strength and endurance of the of the muscles in the chest can help to reduce the chances of getting a lung complication after surgery.

The aim of the INSPIRE study is to compare exercises performed using a hand-held device held up to the mouth, through which patients breathe in and out, with recommended exercises that are provided in an information leaflet and are used in current care. Training will take approximately 15 minutes twice a day and can be performed at home whilst sitting down. Some studies have shown that training for as little as two weeks before a major operation halves the risk of lung complications.  

The INSPIRE study will involve 2500 adult patients undergoing operations in the chest or stomach recruited from several hospitals across the UK. The study design includes an internal pilot phase to ensure deliverability of the full randomised controlled trial (RCT). Patients will be followed up for six months after randomisation and will be asked to complete quality of life questionnaires.

The INSPIRE study is funded by the NIHR HTA Programme (project number 16/140/07). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR HTA or the Department of Health.

Status: In set up (recruitment begins June 2019)

Contact Information

Chief Investigator: Dr Maria Pufulete

Trial Co-Ordinator: Dawn Phillips

E-mail: inspire-study@bristol.ac.uk

 

The effectiveness on post-operative recovery of using ‘off pump’ self-expanding tissue valves (IPVR) versus ‘on pump’ conventional tissue valves (PVR) for pulmonary valve replacement: an early phase randomised controlled trial (RCT)

In(jectable) V(alve) I(mplantation) T(rial) (InVITe)

funder: NIHR, Bristol Cardiovascular Biomedical Research Centre (Cardiovascular Theme), and the British Heart Foundation 

Sponsor: University Hospitals Bristol 

REC Number: 15/SW/0179

Many patients who are born with problems with their heart valves require repeated operations throughout their life to replace the affected valves. The standard operation for valve replacement involves opening the chest, extensive exposure by the surgeon and the use of the heart-lung bypass machine to take over the function of the heart and lungs (pumping blood and oxygen through the body) during the operation. The heart-lung bypass machine is an extremely useful tool, however, using it is not without risk and it often takes patients many weeks to recover after an open heart operation.

Recent advances in technology have introduced new replacement valves which can be ‘injected’ into position with the heart still beating (avoiding the need to use the heart-lung bypass machine) and without a need for the surgeon to expose all the heart. However, the new valve has not been extensively studied and has been used in around 300 patients worldwide so far. Surgeons have reported their experiences but only for small numbers of patients and without comparing their experiences directly with the conventional replacement valves.

InVITe will investigate the effectiveness of injectable pulmonary valve replacement compared to standard pulmonary valve replacement. Patients will be allocated at random (by chance) to receive either the “injectable” valve or standard valve. We 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. We will also determine whether these valves function as well as the conventional ones.

 

 

Contact Information

Chief InvestigatorMr Andrew Parry, Consultant Paediatric Cardiac Surgeon, Bristol Royal Hospital for Children 

Study coordinator: Rachael Heys

E-mail:  invite-trial@bristol.ac.uk

 

Outcome Monitoring After Cardiac Surgery (OMACS)

Sponsor: University Hospitals Bristol 

Status: Ongoing

After cardiac surgery, patients routinely have a follow-up appointment six weeks after discharge. After this appointment the patient is usually referred back to the care of their general practitioner (GP) and no longer receives care from, nor is followed up by, the cardiac surgery team. This means that we have little information about their long term health.  This study will allow long-term data collection after cardiac surgery.

The aim of OMACS is to collect information about the medium and long-term health status of patients who have had cardiac surgery.

We will ask participants to complete a questionnaire relevant to the surgery they have received and / or a quality of life questionnaire at 3 months and 12 months post-operatively.

Participants will be given a choice of participating electronically or via post to maximise the convenience for participants.

We will ask potential participants for consent to use their data collected as part of their clinical care at this hospital (Bristol Royal Infirmary) or at other hospitals using nationally collected data (called Hospital Episode Statistics or HES).

This information will be used to help us design future research and answer research questions in ongoing studies.

OMACS also includes some substudies:

  1. The first substudy has investigated whether the presentation style and format of the information leaflets provided to potential participants has an effect on the consent rates to the study.  We have used the format that resulted in the highest number of consented patients to use for the remainder of the study, and to design patient information templates for other studies.
  2. The second substudy is looking at the wording of cover letters that accompany participant questionnaires, and whether the number of questionnaires returned can be increased by using particular phrases.

Contact Information

Chief Investigator: Dr Lucy Culliford, Research Fellow

Study coordinator: Dr Lucy Culliford

E-mailomacs-study@bristol.ac.uk

 

Role of potassium channels in sustaining physiological responses of human resistance arteries

Funder: British Heart Foundation 

Sponsor: University of Oxford 

Status: Recruiting

The way arteries in the heart constrict and dilate is important for controlling the blood flow through them.  This process is disrupted in people with coronary artery disease, leading to heart attack and strokes.  We want to understand how the diameter of coronary arteries is controlled normally and how this changes in diseased arteries, which are lined with fatty deposits (plaque).  

In the Oxford Artery study we are recruiting patients undergoing heart valve operations (who have normal arteries) and asking them to donate the piece of tissue from the heart that gets removed during surgery and is normally discarded.  We are conducting laboratory experiments on the arteries found in these pieces of heart tissue.  We want to establish how electrical events within the wall of these arteries control their diameter and therefore the blood flow through them.  This research may lead to new treatments for people with coronary artery disease. 

The research is being carried out at Oxford University and we are assisting by recruiting patients and providing samples and clinical data.

If you have taken part in the Oxford Artery study and you are interested in how we use your data, please see our Privacy Statement.

Contact Information

Chief Investigator: Dr Kim Dora

Study coordinator: Rachael Heys

E-mailoxford-artery-study@bristol.ac.uk

 

Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: Propofol cardioplegia for myocardial protection randomised controlled trial: the PROMPT2 Study

NIHR funding stream: EME

REC Number: TBC

Status: Study set-up

Almost 2.3 million people in the UK are living heart disease and >36,000 cardiac surgery operations are carried out each year. During surgery the heart is isolated from the rest of the circulation and a heart-lung machine is used to supply oxygen to the blood and pump it around the body. The heart is stopped and provided with nutrients by a cardioplegic solution that is injected directly into the heart arteries. This allows the surgeon to operate on the heart while it is still and not filled with blood but looking after the heart in this way during surgery is not ideal. The heart muscle can become short of oxygen, and when the heart is restarted, and blood starts to flow again the muscle can be harmed.

The damage is believed to be caused mainly by the formation of highly reactive molecules known as ‘free radicals’ in the heart muscle during the time it is short of oxygen. Propofol is a general anaesthetic widely used in cardiac surgery and research suggests that propofol could protect the heart muscle against damage from free radicals. We want to 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.

 

Contact Information

Chief Investigator: Professor Gianni Angelini

Trial Co-Ordinator: Wendy Underwood

E-mail:  prompt2-trial@bristol.ac.uk

 

Unit Role: Recruiting Centre

The PROVE study is run by the University of Bristol.  They believe that some elements of stem cells, (which are present in bone marrow) also exist in arteries and veins.  These cells are potentially useful as they could be used to form new arteries and thus improve the circulation of patients suffering from coronary heart disease.

Veins of the leg or arteries of the arm are used during CABG surgery.  The surplus of these vessels is discarded at the end of the operation so we are asking patients if we can use them to study if they contain the original cells capable of forming new arteries.

  • Patients with more than one vessel disease having CABG+/valve are approached to take part in this research
  • Observational trial so patients can participate in PROVE and another study

Contact Information

Research Nurse: Emma Hopkins 

 

The Renoprotective value of Leukodepletion in Heart Valve surgery: an external feasibility randomised controlled trial

Funder: NIHR/RfPB 

Sponsor: University Hospitals Bristol 

Status: Analysis 

 People who have surgery to repair damaged heart valves can suffer damage to their kidneys after their operation. This damage is caused by the heart-lung bypass machine, which takes over the job of pumping blood around the body whilst the heart is being operated on. The white blood cells (leukocytes) circulating in the blood react to the materials in the heart-lung bypass machine, which ‘activates’ them and causes inflammation throughout the body. This inflammation can damage the kidneys. 

The ROLO study is looking to see if removing the ‘activated’ white blood cells from the blood (through a special filter in the heart-lung bypass machine) during surgery will reduce damage to the kidneys. Patients undergoing heart valve operations were allocated by chance to having their blood filtered using either a standard filter, which doesn’t filter out the white blood cells, or a new filter, which filters the blood in the same way as the standard filter, but also filters out the white blood cells.

Participants were followed-up for three months after surgery to see if they developed kidney injury.

Participants were recruited from Blackpool Teaching Hospitals NHS Foundation Trust. CTEU Bristol has been contracted to provide trial and data management services for the study, including the statistical analyses.

The study is now closed and the final report has been submitted to the funder

Department of Health Disclaimer: The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the RfPB, NIHR, NHS or the Department of Health.

Contact Information

Study coordinator: Lucy Dabner

E-mailrolo-trial@bristol.ac.uk

 

Safety and efficacy of coronary venous arterialisation in patients with refractory angina: a prospective, protocol based case series (The Venous Study)

Angina occurs when the blood vessels (arteries) that supply blood to the heart become hardened and narrowed, restricting blood follow to the heart. This results in pain in the chest, usually triggered by physical activity or stress, when the heart rate increases and therefore needs more blood and oxygen.  Most patients with angina are treated with medications that can increase the flow of blood to the heart and reduce their risk of having a heart attack. If the pain persists or there is severe narrowing of one or more arteries, percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) may be offered. PCI is a non-surgical procedure which involves inserting a short wire-mesh tube, called a stent, into the narrowed artery. CABG is a surgical procedure which involves taking a blood vessel (known as a graft) from another part of the body and attaching it to the artery above and below the narrowed area.

A small proportion of patients with angina are not suitable for PCI or CABG. These patients have a serious condition, are difficult to treat and have a poor quality of life. 

The Venous Study proposes a novel type of surgery to try and restore blood flow to the heart, using the heart’s veins rather than arteries.  The surgery can be performed in one of two ways. Instead of connecting the graft to an artery as in CABG, it can be connected to a vein; this is called coronary arterial venous grafting (CAVG).  Another method of restoring blood flow using veins is to supply the blood through the large blood vessel behind the heart that is formed by a collection of veins (the coronary sinus). This method is referred to as coronary sinus grafting (CSG), because the bypass graft is attached to the coronary sinus either where it opens inside one of the heart chambers (the right atrium), or on its side (on the outside of the heart).  The Venous Study, will offer CAVG or CSG to patients who have severe angina and are unable to have conventional treatments and for whom there are no other possible treatments. We will conduct a type of study known as an IDEAL (Idea, Development, Exploration, Assessment, Long term monitoring) phase 1 case series. This type of study is designed to evaluate the safety of novel surgical treatments. Alongside The Venous Study, we will also conduct a sub-study involving interviews and audio-recording of consultations between healthcare professionals and patients. This sub-study will help us understand and improve how information about the new surgery is communicated to patients.

Funder acknowledgement: NIHR

REC Number: TBC

Status: Set-up 

This study is funded by National Institute of Health Research (NIHR). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health. 

Contact Information

Chief Investigator: Prof Gianni Angelini

Trial Co-Ordinator: Dr Abby Willcox

E-mail: venous-study@bristol.ac.uk

 

Preoperative Volume Replacement vs. usual care in Diabetic patients having CABG surgery: a randomised controlled trial

Diabetes mellitus is a major risk factor for complications in patients having coronary artery bypass graft (CABG) surgery. Such complications pose a serious threat to patients and prolong intensive care and hospital stay. Renal failure is more common after coronary artery bypass grafting in diabetics than in non-diabetics. Volume depletion is associated with a low glomerular filtration rate, and may lead to acute renal impairment/failure. 

Preoperative volume replacement therapy is reported to increase the glomerular filtration rate and we hypothesised that this would reduce renal impairment.

VeRDiCT was designed to test whether diabetic patients randomised to pre-operative volume replacement would have less problems with renal impairment after surgery. The study recruited patients from the Bristol Royal Infirmary, and ran in parallel with a study in India.

Patients who consented to take part in VeRDiCT were allocated to either standard care or to volume replacement therapy, which meant receiving an intravenous drip of Hartmann’s solution for about 12 hours before their operation. Standard care meant that the patients only had volume replacement if it was needed for another clinical reason. Numerous samples of blood and urine were collected during the patient’s stay in hospital and information about the patient’s health on the day that they left hospital was recorded. Patients were followed up by telephone call 6-8 weeks after surgery to assess their wounds and answer questions regarding readmissions, and then again by questionnaire 3 months after surgery to assess their health status and health resource usage.

Recruitment went well and data analysis has been completed. The study results are now being written up, with an aim for publication in the early Summer of 2018.

The study was funded by the Garfield Weston Trust (Ref: PMS/MMS-07/08-3001), and supported by the NIHR Bristol Cardiovascular Biomedical Research Unit and the British Heart Foundation.

The VeRDiCT protocol paper has been published, and can be read here

Contact Information

Chief InvestigatorProf Raimondo Ascione

Trial Co-Ordinator: Maddie Clout

E-mailverdict-trial@bristol.ac.uk

 

Unit Role: Recruiting Centre

Sponsor: Vascular Graft Solutions Ltd

Coronary artery bypass grafts (CABGs) are well-established as the best treatment for those with multiple diseased coronary vessels. Most people undergoing CABG require more than one graft, to both the left and right side of the heart.

The standard operation (80-90% of patients ) is to use one of the mammary arteries and a saphenous veins (SVG) from the leg or radial artery from the arm. CABG provides excellent short and medium term success, but its long-term success may be limited by failure of the vein grafts. Ten years after CABG, around half of vein grafts have become diseased / blocked, although current drug therapy – such as aspirin and statins – may reduce this failure. Blocked / diseased grafts means that the patient may develop recurrent angina and may require further treatment / possibility of a re-do op.

The ‘VEST’ is a delicate braided wire ‘sleeve’ which is threaded over the bypass vein graft, during the operation. The device remains in place forever, providing external support to the vein graft, in-order to prevent it from becoming deformed. Research to date has shown that using the device may improve the condition of the graft over time. The Vest devices are approved and being commercially used in Europe and Israel.

The aim of the study is to enhance the clinical data available for use of the ‘VEST’ in bypass grafts and obtain long-term data. It is currently in use in UK and Europe and has been previously used in two clinical studies, too. However, more evidence and data need to be collected and this is the reason for performing this study. The patients in the study will have consented to have a follow up CT scan at 6 months and an angiogram at 2 years post cardiac surgery, in order to assess the patency and uniformity of the saphenous vein graft with the VEST sleeve, when compared with the vein without the VEST sleeve.

Hopefully data from this trial will give a better picture of the long term performance of the VEST product.

Contact Information 

Research Nurse: Emma Hopkins