Status:
RECRUITING
Study on Optimal Temperature During Cardiopulmonary Bypass (THERMIC-4)
Lead Sponsor:
University of Leicester
Collaborating Sponsors:
NHS National Waiting Times Centre Board
Sheffield Teaching Hospitals NHS Foundation Trust
Conditions:
Ischemic Heart Disease
Valvular Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 ca...
Eligibility Criteria
Inclusion
- 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 the elective or urgent setting.
- European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 2 or higher.
- Able to understand and communicate to provide informed consent.
- Able to read and understand the English language.
- EXCLUSION CRITERIA
- Participants may not enter the trial if any of the following apply:
- Patients undergoing coronary artery bypass surgery in combination with other procedures including cardiac or vascular procedures that require deep hypothermic arrest.
- Patients undergoing emergency or salvage surgery.
- Patients undergoing off-pump cardiac surgery.
- Patients who are participating in another interventional trial.
- Unable to provide informed consent.
Exclusion
Key Trial Info
Start Date :
May 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05996120
Start Date
May 20 2024
End Date
February 1 2026
Last Update
April 3 2025
Active Locations (11)
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1
Glenfield Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP
2
Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom, FY3 8NR
3
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom, BS1 3NU
4
Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
Cottingham, United Kingdom, HU16 5JQ