At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Hypothermic Cardiopulmonary Bypass (procedure), Normothermic Cardiopulmonary Bypass (procedure)
- How long the study runs
- Study runs about 21 months (dates as stated)
- About the drug or intervention
- Hypothermic Cardiopulmonary Bypass — procedure: Mild hypothermia (between 32 - 35 °C) during cardiopulmonary bypass · Normothermic Cardiopulmonary Bypass — procedure: Normothermia (active maintenance of temperature between 36.5 °C to 37.5°C; no active cooling below 36.5 °C) during cardiopulmonary bypass
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2024-05-20
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for ischemic heart disease
- • NA - 100 participants
- • In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ischemic heart disease
Where?
- • Leicester - Glenfield Hospital, University Hospitals of Leicester NHS Trust
- • Blackpool - Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
- • Bristol - University Hospitals Bristol and Weston NHS Foundation Trust
- • Cottingham - Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
- • +7 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In order to perform heart surgery, a machine called cardiopulmonary bypass (CPB), or more commonly known as a heart-lung machine, is used to maintain the circulation of oxygenated blood needed by the rest of the body and its organs. Historically, when a patient is connected to CPB, their body is cooled below the normal body temperature. This is known as hypothermia. This is because scientific studies have previously shown that reduced body temperature lowers metabolism and therefore offers more protection to the brain and other organs due to the reduced oxygen requirement. The evidence supporting this practice, however, has been challenged throughout the history of cardiac surgery, with studies supporting that normothermia, or normal body temperature, is a safe alternative. Despite this, the practice of hypothermia has persisted. Published data from a survey of 139 cardiac surgeons in the United Kingdom showed that 84% still routinely employ hypothermic CPB during surgery. To assess whether normothermic or hypothermic CPB is safer, a clinical trial requiring a large sample size and high recruitment rates will be required. Therefore, the investigators aim to assess firstly the feasibility of trial recruitment and allocation adherence in this study. 100 adults across 10 different cardiac surgery centres in the United Kingdom will be recruited to a multicentre feasibility randomised controlled trial comparing normothermia (active comparator) against hypothermia (control comparator) during cardiopulmonary bypass in cardiac surgery. This study will also test the ability of the Cardiothoracic Interdisciplinary Research Network (CIRN), a trainee-led research collaborative, to collect pilot data on Major Adverse Cardiac and Cerebrovascular Events (MACCE) using a regulation-approved electronic application HealthBitⓇ. Participants will also be asked to complete quality of life surveys. The results of this study will subsequently inform a large, adequately powered randomised controlled trial for optimal temperature management during CPB.
More detail
Primary Objective To assess the feasibility of trial recruitment and delivery to target in the United Kingdom of a multicentre randomised controlled trial on normothermia versus hypothermia during cardiopulmonary bypass in adult cardiac surgery. Secondary Objective To assess the feasibility of conducting a multicentre randomized controlled trial (RCT) using a novel Good Clinical Practice (GCP) approved remote data capture as the primary trial database alongside analysis of routinely collected healthcare data. To obtain pilot data, undertaken by the Cardiothoracic Interdisciplinary Research Network (CIRN), to inform a subsequent large, adequately powered RCT for optimal temperature management during CPB.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ deep hypothermic arrest
What the study is looking for
- ✓INCLUSION CRITERIA
- ✓Participants may enter the trial if all of the following apply
- ✓Adult patients (≥ 18 years) scheduled for coronary artery bypass surgery and/or valve replacement/ repair, either in...
- ✓European System for heart Operative Risk Evaluation (EuroSCORE) II of 2 or higher.
- ✓Able to understand and communicate to provide agreement to take part.
See the full criteria
Where Is This Study? (11 UK sites)
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester LE3 9QP, United Kingdom
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool FY3 8NR, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol BS1 3NU, United Kingdom
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham HU16 5JQ, United Kingdom
Golden Jubilee National Hospital, NHS Golden Jubilee
Glasgow G81 4DY, United Kingdom
King's College Hospital, King's College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
Royal Brompton Hospital, Guy's and St Thomas' NHS Foundation Trust
London SW3 6NP, United Kingdom
Harefield Hospital, Guy's and St Thomas' NHS Foundation Trust
London UB9 6JH, United Kingdom
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford OX3 9DU, United Kingdom
Derriford Hospital, Plymouth University Hospitals NHS Trust
Plymouth PL6 8DH, United Kingdom
Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield S5 7AU, United Kingdom
How to Get in Touch
Gavin J Murphy, FRCS, MD, MBChB, BSc
Sponsor contactCONTACT
Ann Cheng, MBChB, MSc
Sponsor contactCONTACT