Status:
RECRUITING
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery
Lead Sponsor:
Unity Health Toronto
Conditions:
Disorder
Heart
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger unde...
Eligibility Criteria
Inclusion
- ≥18 and ≤65 years of age
- Planned cardiac surgery using cardiopulmonary bypass
- Informed consent obtained
- Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
Exclusion
- Patients who refuse participation
- Patients who are unable to receive or who refuse blood products
- Patients who are involved in a preoperative autologous pre-donation program
- Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
- Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1440 Patients enrolled
Trial Details
Trial ID
NCT04754022
Start Date
November 1 2021
End Date
June 1 2026
Last Update
November 21 2024
Active Locations (54)
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1
Maine Medical Center
Portland, Maine, United States, 04102
2
The Cooper Health System
Camden, New Jersey, United States, 08103
3
Columbia University
New York, New York, United States, 10032
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107