NIHRDataInsights/HRCSData huggingface dataset:
Title: A multi-centre randomised controlled trial of Transfusion Indication Threshold Reduction on transfusion rates morbidity and healthcare resource use following cardiac surgery (TITRe 2)
Funder: Department of Health (England)

Abstract: Cardiac surgery centres transfuse over 6% of all units of red blood cell (RBC) used in the UK. Although RBC transfusion is essential in some patients for the management of life-threatening haemorrhage in most cases decisions to transfuse are made because the haemoglobin (Hb) concentration has fallen to a level or threshold at which the physician is uncomfortable. The transfusion threshold varies between units and physicians contributing to wide variation in the percentage of cardiac surgery patients who are transfused with RBC (25% to 95%). The threshold variation stems from a lack of evidence as to what constitutes a safe level of anaemia following cardiac surgery.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. Transfusion may cause complications by reducing patients ability to fight off infection and respond to the stress that surgery puts on the body as well as the better known but rare complication of infection transmission.Randomised trials have suggested that in other patient groups only transfusing when the Hb level drops below 7.0g/dL reduces transfusion rates as well as complications. However to date there has been no large high quality randomised trial of different transfusion thresholds in a population of cardiac surgery patients. We propose to test the hypothesis that lowering the RBC transfusion threshold from a haemoglobin (Hb) level of 9.0g/dL (liberal) control group similar to current practice at most centres) to 7.5g/dL (restrictive) reduces postoperative complications and NHS costs in cardiac surgery patients. The study is a UK multi-centre randomised controlled trial that aims to assign 2000 patients to a restrictive or liberal post-operative transfusion threshold. The primary outcome will be a composite of infectious and ischaemic events in the first three months after randomisation.


Research activity codes: 2.2 FACTORS RELATING TO PHYSICAL ENVIRONMENT;2.1 BIOLOGICAL AND ENDOGENOUS FACTORS
Health categories: CARDIOVASCULAR
Title: Randomised controlled trial comparing foam sclerotherapy alone or in combination with endovenous laser therapy with conventional surgery as a treatment for varicose veins
Funder: Chief Scientist Office (Scotland)

Abstract: NOTE: This project encompasses the long term follow-up for HTA Project: 06/45/02.Up to 15% of men and 25% of women develop varicose veins over their lifetime resulting in 95000 operations being performed each year in the NHS in England alone. The most common treatment offered is surgery which involves stripping out the veins under general anaesthetic. Recently new minimally invasive treatments - foam sclerotherapy and endovenous laser ablation - have been developed for treating varicose veins. These can be given under local anaesthetic freeing up expensive operating theatre time and offering more rapid treatment for a greater number of people. They may also avoid the scars and bruising associated with surgery result in fewer complications and allow a quicker return to normal daily activities and work. However despite good short term results of minimally invasive treatments success in the long term is unclear.We will compare a) surgery b) foam sclerotherapy and c) endovenous laser ablation in combination with foam sclerotherapy. Eligible patients will be recruited at 6 centres and randomised to one of the three treatment options. They will be followed up initially for six months with the intention of extending this to five years. Primary outcome measures include disease specific an generic patient reported outcomes. The technical and clinical success of the treatment will be assessed up to six months again with the intention of extending this to five years. The primary economic outcome will be the incremental cost per quality adjusted life years (QALY) at 6 months; again with the intention of extending this to five years.


Research activity codes: 6.4 SURGERY
Health categories: CARDIOVASCULAR
Title: Does home oxygen therapy (HOT) in addition to standard care improve disease severity and symptoms in chronic heart failure?
Funder: Department of Health (England)

Abstract: Patients with Chronic Heart Failure (CHF) commonly have significant limiting symptoms despite optimal management. The prevalence and clinical relevance of hypoxaemia in patients with CHF is incompletely understood. Currently Home Oxygen Therapy (HOT) in various forms is used commonly despite the absence of evidence of benefit. The present study seeks to address the uncertainties surrounding home oxygen therapy for patients with chronic heart failure who are still severely symptomatic despite maximally tolerated medical therapy. The study will randomise 450 patients equally to its active treatment arms These are (a) best medical therapy without oxygen (b) best medical therapy with daytime Long Term Oxygen Therapy (LTOT for at least 15 hours per day in the home) or (c) best medical therapy with Nocturnal Oxygen Therapy (NOT overnight in the home). Each patient will remain within the study for at least 1 year. All patients will continue active treatment within the study until the last patient recruited has completed their 1 year’s active treatment meaning that the first patient recruited will remain on active treatment for approximately 2 years in total. Patients can withdraw at any point and such incidences will be included within the quality of life analysis.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.7 PHYSICAL
Health categories: CARDIOVASCULAR
Title: A randomised controlled trial to investigate the clinical and cost effectiveness of adding an ablation device-based maze procedure as a routine adjunct to elective cardiac surgery for patients with pre-existing atrial fibrillation (AMAZE)
Funder: Department of Health (England)

Abstract: Atrial fibrillation (AF) is a fast irregular heart caused by abnormal electrical signalling.Both the complications and treatment of AF reduce the patients quality of life and are very costly for the NHS. The maze procedure (cutting and stitching the atrial wall to redirect electrical signals) can stop AF but is not widely used due to complexity. Ablation devices consisting of a probe and energy source can be used to make the maze procedure simpler quicker and safer. The use of these devices is creeping into practice but has not been rigorously evaluated.This multicentre prospective randomised controlled trial will test the hypothesis that adding a modified maze procedure (using an AF ablation device) to elective cardiac surgery in patients with AF will improve their quality of life as well as being cost-effective from an NHS perspective. It responds to calls from the European Heart Rhythm Association and European Cardiac Arrhythmia Society for high quality prospective multi-centre trials to adopt consistent definitions of procedural success in long-term assessments of the safety and efficacy of ablation devices. The results of this trial will inform patients clinicians and the NHS about the routine adoption of this new technology.Eligible patients will be elective cardiac surgical patients undergoing major cardiac surgery (eg coronary valve or combined operations) with a history of paroxysmal persistent or chronic AF beginning more than 3 months before the date of their operation. Patients will be randomised (by telephone or fax) by the coordinating centre (Papworth) on the day of surgery.Quality of life EQ-5D medication resource use mortality and stroke data will be collected at 6 12 and 24 months and annually thereafter. Continuous ECG recording will be taken over several days at baseline 12 months and 24 months.


Research activity codes: 6.4 SURGERY;6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: CARDIOVASCULAR
Title: A randomised controlled trial of the LUCAS mechanical compression/decompression device for out of hospital cardiac arrest.
Funder: Department of Health (England)

Abstract: Design: Cluster randomised controlled trial. Randomisation units are ambulance and rapid response vehicles.Setting: Pre-hospital care.Target population: Patients suffering out of hospital cardiac arrest where a resuscitation attempt is appropriate. Exclusions are age under 18 years pregnancy and traumatic cardiac arrest.Health technologies being assessed: Chest compressions given using the LUCAS (Lund University Cardiopulmonary Assistance System) mechanical compression/decompression device versus standard manual compression.Measurement of costs and outcomes: Primary outcome: survival to 30 days post cardiac arrest. Secondary outcomes: 1. survived event (survival to hospital); 2. Survived to hospital discharge; 3. survival to 3 and 12 months; 4. health related quality of life at 3 and 12 months (SF12); 5. neurological outcome at discharge from hospital (Cerebral Performance Category (CPC) score 1-2 v 3-5); 6. neurological outcome at 12 months (Mini Mental State Examination (MMSE)); 7. anxiety and depression at 12 months (Hospital Anxiety and Depression Scale (HADS)); 8. Post Traumatic Stress at 12 months (PTSD civilian checklist (PCL-C)); 9. hospital length of stay; 10. intensive care length of stay. Outcomes up to hospital admission will be reported by the attending paramedic. Survivors will be flagged at NHSCR to ensure that all deaths are notified. Follow-up visits to surviving patients wanting to take part will be carried out by a Research Nurse at 3 and 12 months. Sample size: 418 clusters; 4344 participants. This is sufficient to detect an increase in survival to hospital discharge from 5% in the manual compression group to 7.5% in the LUCAS group.Expertise. The trial will be co-ordinated by the Warwick Medical School Clinical Trials Unit. The Unit has extensive experience of management of large-scale health care evaluations. The trial staff will include a co-ordinator data manager programmer statistician and health economist as well as paramedic research fellows who will undertake training and liaison with participating paramedics. The trial will be conducted according the Units Standard Operating Procedures and managed according to the units usual practice. The expertise of the applicants covers all relevant areas including emergency medicine resuscitation intensive care health economics pre-hospital care trial management and statistics.


Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR
Title: An evaluation of the effect of an angiotensin-converting enzyme (ACE) inhibitor on the growth rate of small abdominal aortic aneurysm
Funder: Department of Health (England)

Abstract: The hypothesis that an ACE-inhibitor reduces abdominal aortic aneurysm (AAA) growth rate will be investigated. The patients identified with an abdominal aortic aneurysm less than 5.5cm in diameter will be invited to take part in the trial. At entry their bsystolic blood pressure will be less than 150mm/Hg.In this pilot 3-arm randomised controlled trial: The three interventions are ACE-inhibition with perindopril versus equivalent blood pressure reduction with amlodipine (a calcium channel blocker) versus placebo. By comparing the effects in the perindopril and amlodipine arms this design will permit an evaluation of any blood pressure independent effects of perindopril.The pilot trial will recruit approximately 270 patients from aortic aneurism screening sites in or near to London. They will be seen and assessed with an ultrasound examination every three months for a period of 24 months.If during the trial an individual patient’s aneurysm should reach 5.5 cms in diameter this patient will be referred back to the vascular surgeons in the normal surveillance programme. This assessment should take place within 2 weeks.Pending results of this pilot trial working with the local and National Aneurysm Screening programme a larger definitive 3-arm randomised controlled trial will be conducted to investigate the hypothesis that blood pressure reduction with an ACE-inhibitor slows the rate of small AAA growth preferentially compared with other antihypertensive agents. Aneurysm-related mortality morbidity and quality of life will be the major secondary end-points.A blood lipid profile will be performed at screening and serum creatinine and electrolytes will be monitored during the trial.A euroqol questionnaire will be administered at the start of the trial and at one year. A health resource questionnaire will be administered at the end of the trial.The trial will initially be undertaken at four London sites: Charing Cross St Marys St Thomas and the Royal Free hospitals and also at the University Hospital of Coventry and Warwickshire.


Research activity codes: 5.1 PHARMACEUTICALS
Health categories: CARDIOVASCULAR
Title: The role of ultrasound compared to biopsy of temporal arteries in the diagnosis and treatment of giant cell arteritis
Funder: Department of Health (England)

Abstract: Giant Cell Arteritis (GCA) causes inflammation and narrowing of blood vessels and can cause blindness in one third of patients. It is important that a prompt accurate diagnosis of GCA is made and treatment given as steroids for two or more years. Currently there is no 100% accurate test for GCA. Patients usually have new headache and scalp tenderness typically with an abnormal blood test. However it can be difficult to distinguish non-serious forms of headache from GCA; infection produces similar abnormal blood results. If there is a suspicion of GCA treatment with steroids is started straight away. To confirm a diagnosis the patient will need a biopsy of a temporal artery (a minor procedure performed under local anaesthetic to remove a sample of one of the scalp arteries). However up to 44% of patients will have a normal biopsy. Therefore it is difficult to know if a patient with a normal biopsy does or does not have GCA. Withdrawing steroid treatment may increase the risk of blindness. Continuing treatment in a patient without GCA increases the risk of side effects (e.g. weight gain infection risk osteoporosis and fracture risk high blood pressure diabetes cataracts). It is important to improve diagnostic tests for GCA. Another test to help in diagnosing GCA is an ultrasound scan of the arteries in the side of the head and under the arms Ultrasound does not involve surgery; it is a simple test which can be performed as an out patient. Gel is applied to both sides of the head and under each arm. A sound probe is placed over the artery at each site to produce the scan.The investigators study will examine the role of ultrasound in diagnosis of 402 patients with suspected GCA. All patients will have an ultrasound examination in addition to biopsy within a week of starting steroids. Patients will be treated according to usual practice. After six months the investigators will reassess the diagnosis. The investigators will look at the accuracy of ultrasound compared with or combined with biopsy. The investigators will look at how a doctors knowledge of ultrasound results or biopsy results alone would affect the diagnosis and recommendation to continue or stop steroid treatment. The investigators will assess whether knowledge of both results together would alter the diagnosis and treatment. The investigators will collect information to estimate the costs of different ways of diagnosing GCA in relation to the impact on quality of life.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CARDIOVASCULAR
Title: Optimal strategies for monitoring lipid levels in patients at risk or with cardiovascular disease: best marker for monitoring and cost-effectiveness of different monitoring frequencies
Funder: Department of Health (England)

Abstract: Cholesterol is an essential lipid for normal function; however high levels are associated with several health problems in particular cardiovascular disease (CVD). Lipid measurement is essential for accurately assessing an individual’s overall risk of cardiovascular disease and coronary heart disease (CHD): high total (TC) high low-density lipoprotein (LDL) and low high-density lipoprotein (HDL) cholesterol predict increased risk. Screening and long-term monitoring of cholesterol levels requires interpretation of initial levels and also of sequential levels over time. Lipid guidelines for primary prevention of CVD and CHD recommend a targeting level for lipid level and how to interpret initial measurements; however do not usually specify how to carry out subsequent monitoring in primary prevention and guidelines vary in their recommendations. For secondary prevention most guidelines and the Quality Outcomes Framework have suggested close monitoring of those on treatment - usually at least 6 monthly or yearly. However the 2008 NICE guideline has taken a radical departure from convention. For primary prevention the new guideline suggests a fire and forget strategy. The proposed work therefore aims to provide evidence for the management of lipids for primary and secondary prevention.The objectives of this project are: •To identify the relative ability of different lipid measures (single or combination) to detect important changes in lipid status •To estimate the incremental gains and costs of different strategies (lipid measurements and intervals) for risk assessment and monitoring of lipid levels in patients at risk of or with cardiovascular disease •To develop and populate an economic model of lipid monitoring •To explore how the choice of lipid measure impacts on risk assessment of CVD compared with original risk scores and•To disseminate the impact of our findings on CVD risk assessment.We will use a mixture of methods to achieve these objectives: systematic reviews will identify the predictive values of different lipid markers and the effectiveness of lipid lowering treatment for both primary and secondary prevention; the (secondary) analysis of individual patient data from observational studies from randomised controlled trials and from routinely collected data will provide estimates of the monitoring performance of the different lipid measures and the incremental gains and costs for CVD risk assessment; the cost-effectiveness analysis will allow us to develop and populate an economic model for lipid monitoring; and we will run a conference for the dissemination of the work.


Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CARDIOVASCULAR
Title: Effect of Remote Ischaemic preConditioning on Clinical outcomes in patients undergoing Coronary Artery bypass graft
Funder: Medical Research Council

Abstract: Scientific Abstract|Research Design: Multi-centre double-blind randomised controlled clinical trial.|Study Population: High-risk patients (additive Euro-SCORE of 6 or more) undergoing CABG1valve surgery.|Planned Interventions: Remote ischaemic preconditioning (RIC) comprising three 5 min cycles of inflation (to 200mmHg) and deflation of a cuff placed on the upper arm. Control will comprise placing an un-inflated cuff on the upper arm for 30 minutes.|Proposed outcome measures: Primary outcome: Major adverse cardiac and cerebral events at one year (MACCE- death, myocardial infarction, revascularisation, stroke). Secondary outcomes: Peri-operative myocardial and renal injury; Length of ITU/hospital stay and inotrope score; 6 minute walk test; Quality of life analysis and cost-effectiveness analysis. There will be an echo substudy assessing left ventricular ejection fraction.|Assessment and follow up: Outcome measures will be assessed from the patient GP and medical notes, questionnaires (at 3, 6, 9 months) and 6 week and one year outpatient appointments. Safety will be assessed using a Standard Operating Procedure. |Proposed sample size: In the SYNTAX study, the MACCE rate was 12.4% at 12 months in CABG patients at lower risk than those proposed for this trial (mean EuroSCORE 3.8)(Serruys et al NEJM 2009;360:961). In a study of high-risk patients with left main stem coronary lesions the MACCE rate at 12 months was 25% (Lee et al JACC 2006; 47:864). For our high-risk patients we have estimated a MACCE rate of 20%. Therefore, to detect a 27% relative risk reduction in this primary endpoint (from 20.0% to 14.6%), with a power of 80% and a significance level of 5%, a sample size of 770 patients will be required for each trial arm (1540 in total). A trial of this size would detect an observed relative reduction of 20% (i.e. a risk ratio of 0.8) as statistically significant based on an event rate in the control arm of 20%. To allow for dropouts (4-5% in SYNTAX study) we plan to recruit 1610 patients in total based on 4.5% dropout rate. |Statistical analysis: Survival analyses will be carried out for the primary MACCE clinical endpoint at one year. MACCE as well as individual components (e.g. mortality); hazard ratios and confidence intervals, together with p-values will be calculated using Coxs proportional hazards modelling. All analyses will be carried out on an intention-to-treat basis. |Project timetables including recruitment rate: Total duration of study: 48 months. (1) 0-6 months- Study preparation; (2) 6-30 months- Patient recruitment; (3) 18-42 months- One year follow-up; (4) 42-48 months- Data analysis, reporting and dissemination of results. To recruit 1610 high-risk CABG1valve patients over 24 months, each of the 9 recruiting centres will need to recruit on average 2 patients per week (180 patients in total), which is about 25% of the eligible 7-10 patients per week.|


Research activity codes: 6.7 PHYSICAL;3.3 NUTRITION AND CHEMOPREVENTION
Health categories: CARDIOVASCULAR
Title: Biomedical Catalyst – Demonstration of a low cost implantable blood pump
Funder: Medical Research Council

Abstract: Advanced heart failure is a large and growing healthcare challenge not adequately met by traditional medical management, cardiac resynchronisation or transplantation. Ventricular assist devices (VADs) can address this need and have shown very promising clinical results. However, existing VADs are expensive, have high utilisation costs due to significant complications and require extensive invasive surgery for implantation. Calon’s MiniVAD addresses these problems with a smaller pump, reduced blood damage and significantly improved health economics. This project proposes the development of novel blood damage assays and the subsequent detailed in-vitro and in-vivo evaluation of the MiniVAD to provide the performance and safety data necessary to support a regulatory application to begin human clinical studies.


Research activity codes: 5.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR