National Cardiac Surgery Clinical Trials Portfolio

Clinical Study Group 1 (Long Term Outcomes and Quality of Life)

Meet the team

STICH3-BCIS-4

A multi-centre randomised trial of surgical versus percutaneous revascularisation of ischaemic left ventricular dysfunction in the United Kingdom, with embedded internal pilot and health economic analysis

Co-chief investigators: Professor Gavin Murphy/Professor Divaka Perera
Clinical Trials Unit: Leicester
Funder: NIHR HTA
Recruitment Target: 630
Contact details:  bcis-4@leicester.ac.uk 
Planned number of sites: 28
Planned number of patients: Main trial-630; Internal Pilot 0.7 participants per month per site
Study Design and Main Study Outcome:  Multi-centre, open label, parallel group, RCT of two common revascularisation strategies in people with ILVSD
Primary Outcome: Time to a composite endpoint of all-cause mortality or cardiovascular hospitalisation

ROMA-Women UK (The UK arm of the international ROMA-Women Trial)

Randomised comparison of the Outcomes of single vs Multiple Arterial grafts trial in Women (ROMA-Women)

Chief Investigator (UK) Professor Gavin Murphy
Clinical Trials Unit: University of Leicester
Funder: British Heart Foundation
Multi-Centre trial 15 open sites to date
Planned number of sites: 20 (UK)
Planned number of patients: 250 (UK)
Contact details:  roma@leicester.ac.uk
Study Design:  An international, multi-centre, randomised controlled cardiac trial looking at women aged ≥18 undergoing primary isolated non-emergent coronary artery bypass surgery (CABG).  Intervention is comparing single vs multiple arterial grafts.

TRICS-IV (The UK arm of the international TRICS IV Trial)

Transfusion Requirements in Cardiac Surgery (TRICSIV)

Chief Investigator (UK): Professor Gavin Murphy
Clinical Trials Unit: Leicester
Funder: NIHR HTA
Planned number of sites: 22 NHS Trusts (UK)
Planned number of patients: 320 (UK)
Contact details:  tricsiv@leicester.ac.uk
Study Design: An international, multi-centre, randomised controlled cardiac trial to assess liberal vs restrictive transfusion strategies/thresholds in younger patients (aged ≤65) undergoing surgery on cardiopulmonary bypass (CPB), with embedded health economic questionnaire (UK arm only) 

DECIDE-CAD

Mixed methods co-design and evaluation of a DECIsion Support Tool to enable shared DEcision making with people who are considering revascularisation options for Coronary Artery Disease (DECIDE-CAD)

Chief Investigator: Ann Cheng
Clinical Trials Unit: Leicester
Funder: NIHR Doctoral Fellowships
Planned number of sites: 1
Planned number of patients: 40
Contact details: decidecad@leicester.ac.uk
Study Design: Feasibility Study

Clinical Study Group 2 (Prehabilitation)

Meet the team

FitForHeartOp

The development and evaluation of two Prehab interventions for patients undergoing elective and urgent heart surgery

Clinical Trials Unit: University of Bristol
Funder: NIHR Programme Grants for Applied researcher
Chief Investigator: Maria Pufulete and Ben Gibbison
Contact Details: cardiac-prehab@bristol.ac.uk

Aim of the research
The aim of our programme is to design and test two prehabilitation (Prehab) interventions: one each for for urgent and elective heart surgery patients. Urgent patients must stay in hospital and have their operation quickly (typically 11 days). Elective patients spend time at home before their operation (about 2 months)

Background to the research
Over 32,000 people have heart operations every year in the UK. Many of these people are unfit. Patients with poor physical and mental fitness have more complications after surgery, recover more slowly and have a poorer quality-of-life. We want to determine whether Prehab, which improves fitness with exercise, dietary and psychological support, can speed recovery, improve quality-of-life and keep people out of hospital after their operation

Design and Methods
Our research is in 5 different work packages (WP)

WP1: We will interview patients awaiting surgery, healthcare professionals and those who have set up Prehab programmes in other surgical specialties to understand their views of Prehab

WP2: We will assemble 4 panels of experts – patients, Prehab experts, a Prehab “Champions group” and a group to ensure Prehab can be delivered in the NHS. These groups will design the two Prehab interventions and determine how they will be implemented. We will conduct more interviews with patients and healthcare professionals to aid this

WP3: We will conduct a feasibility study to test the two interventions out in a group of 60 people. We will interview some of them and ask them what they think of Prehab. We will also collect information about how many people we recruit and whether they follow their Prehab programme

WP4: We will conduct a randomised controlled trial where people will be allocated by chance to receive either the usual care at their hospital or the usual care and Prehab. We will recruit 790 participants having elective surgery. We will measure their quality-of-life after surgery and how many days they have been out of hospital by 3 months as well as other important measures

WP5: We will work with our Champions Network, stakeholder groups and an NHS Impact Accelerator Unit to develop a way that Prehab can be funded and rolled-out in the wider NHS

Patient and Public Involvement and Engagement (PPIE)
This programme of research was designed with the PPIE group brought together during our Programme Development Grant.  They decided how we should design the Prehab intervention, what needed measuring in the main study, and at which timepoint.  They also produced "guiding principles" of what is needed to make a Prehab acceptable, feasible and engaging for patients.

Clinical Study Group 4 (Minimally Invasive and Heart Valve Surgery)

Meet the team

FARSTER-CARE

A multi-centre randomised controlled trial of standard care versus an accelerated care pathway after cardiac surgery (FARSTER-care)

Clinical Trials Unit: York Trials Unit
Funder: NIHR HTA
Chief Investigator: Professor Dumbor L Ngaage,  Consultant Cardiac Surgeon at Hull University Teaching Hospitals NHS Trust
Planned Number of Sites: 16
Planned Number of Patients: 588
Contact Details: farstercare-trial-group@york.ac.uk

Study Design and Main Study Outcome:  The objectives of FARSTER-care will be addressed using a multi-centre, two arm, parallel group, open RCT, including an internal pilot study and embedded health economic analysis. The trial will recruit 588 cardiac surgery participants who have had a sternotomy at UK centres over 24 months and will randomise participants 1:1 to the FARSTER-care (intervention) or standard care (control) arms. Participants in the intervention arm will have specialist outpatient review at three weeks after hospital discharge, followed by commencement of CR from four weeks. Participants in the standard care arm will receive standard post-sternotomy cardiac surgery care which includes specialist outpatient review at six weeks after hospital discharge, followed by commencement of CR from eight weeks. The primary outcome is the difference in ISWT (meters walked) between the treatment groups at six months post-randomisation

PACES

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after Coronary Artery Bypass Surgery (PACeS)

Chief Investigator: Marc Gillinov and John Alexander (International); Professor Enoch Akowuah (UK)
Funder: NIH (NHLBI), USA
Clinical Trials Unit: Academic Cardiovascular Unit, Middlesbrough
Planned number of sites: 77 (International); 11 (UK)
Planned number of patients: 3200 (International); 400 (UK)
Contact details: stees.acu@nhs.net
Design: A prospective, multi-centre, open label, randomised trial (1:1)
Primary effectiveness endpoint: composite of death, stroke, transient ischemic attach (TIA), myocardial infarction (MI), and systemic arterial or venous  thromboembolism (DVT/PE) at 90 days after randomisation

PRIMARY

Percutaneous or Surgical Repair in Mitral Prolapse And Regurgitation for ≥60 Year-Olds (PRIMARY)

Chief Investigator: Professor Jo Chikwe (International); Professor Enoch Akowuah (UK)
Clinical Trials Unit: Academic Cardiovascular Unit, Middlesbrough
Funder: NIH (NHLBI), USA
Planned number of sites: 75 (International); 11 (UK)
Planned number of patients: 450 (International); 100 (UK)
Contact details: stees.acu@nhs.net
Study Design and Main Study outcome:
Design: A prospective, multi-centre, open label, randomised trial (1:1)
Primary Aim: To demonstrate the long-term safety and effectiveness of mitral valve transcatheter edge-to-edge repair (TEER) vs surgical repair in primary, degenerative MR
The primary effectiveness endpoint is: All-cause mortality, valve re-intervention, hospitalisations/urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomisation to a minimum of 3 years post intervention

AFFECT

Optimum therapy for those with Atrial Fibrillation aFtEr Completing MiTral valve repair surgery - The AFFECT trial
Lead Principal Investigator: Professor Enoch Akowuah
Clinical Trials Unit: Academic Cardiovascular Unit, Middlesbrough
Funder: NIHR Health Technology Assessment Programme Grant
Recruitment Target: 1282
Contact details: stees.affecttrial@nhs.net
Aim is for first site to open in March 2025 - The James Cook University Hospital, Middlesbrough
Planned phased roll-out of 25 cardiac centres across the UK in 9 months initial pilot recruitment phase

Clinical Study Group 5 (Organ Protection)

Meet the team

THERMIC-IV (UK Trainee-Led Trial

Normothermic Versus Hypothermic Cardiopulmonary Bypass In Adult Cardiac Surgery: A Multicentre Feasibility Randomised Controlled Trial

Clinical Trials Unit: University of Leicester
Chief Investigator: Professor Gavin Murphy
Planned number of sites: 10
Planned number of patients: 100
Contact details: thermic4@leicester.ac.uk
Study Design and Main Study Outcome: Parallel group, open label, statistician blinded, multicentre, randomised controlled feasibility trial. To assess the feasibility of trial recruitment and delivery to target of a UK multicentre randomised controlled trial on normothermia versus hypothermia during cardiopulmonary bypass in adult cardiac surgery

PROPHESY-2

PROthrombin complex concentrate versus fresh frozen Plasma for bleeding in adults undergoing HEart SurgerY 

Chief Investigator: Professor Laura Green
Clinical Trials Unit: NHS Blood and Transplant
Funder: NIHR HTA
Planned number of patients: 496
Contact details: prophesy2trial@nhsbt.nhs.uk
Study Design: a phase III, pragmatic, non-blinded, multi-site Randomised Controlled Trial
Main Study Outcome: To determine if treatment of bleeding with PCC in adult patients who are actively bleeding within 24 hours of cardiac surgery is superior to fresh frozen plasma (FFP) with respect to a composite of mortality, organ failure or infection, up to and including 90 days from randomisation

CO2

Carbon dioxide insufflation and brain protection during open-heart surgery

Chief Investigator: Ben Gibbison 
Clinical Trials Unit: Bristol Trials Centre
Funder: NIHR EME
Planned number of sites: 12
Planned number of patients: 704
Contact details: co2-trial@bristol.ac.uk
Study Design and Main Study Outcome: Single centre Blinded Randomised Controlled Trial to test the hypothesis that CDI prevents brain injury in patients undergoing heart surgery
Primary Outcome: acute ischaemic brain injury within 10 days post-surgery based on new brain lesions identified with DW MRI or clinical evidence of permanent brain injury

Clinical Study Group 7 (Infection Prevention)

Meet the team

ROSSINI-Platform*

Reduction of surgical site infection with a platform trial utilising a 'Basket-MAMS' design

Clinical Trials Unit: Birmingham Trials Unit
Chief Investigator: Professor Tom Pinkney
Contact Details: thomas.pinkney@uhb.nhs.uk
Funder: NIHR HTA
Planned number of sites: 20
Planned number of patients: 3000
Study Design and Main Study Outcome:
Multiple parallel RCTs in different surgical cohorts, utilising a ‘Basket-MAMS’ design to simultaneously assess multiple interventions. The cardiac surgery cohort will recruit >3000 participants.

*The cardiac surgery arm of the ROSSINI Platform will be led by members of CSG7, Vaja, Rogers, Tanner and Roach