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Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

RECRUITINGN/ASponsored by Unity Health Toronto
Actively Recruiting
PhaseN/A
SponsorUnity Health Toronto
Started2021-11-01
Est. completion2025-12
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations4 sites

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 undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
Inclusion Criteria:

1. ≥18 and ≤65 years of age
2. Planned cardiac surgery using cardiopulmonary bypass
3. Informed consent obtained
4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion Criteria:

1. Patients who refuse participation
2. Patients who are unable to receive or who refuse blood products
3. Patients who are involved in a preoperative autologous pre-donation program
4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Conditions5

Cardiac SurgeryDisorderHeartHeart DiseasePostoperative

Locations4 sites

Maine

1 site
Maine Medical Center
Portland, Maine, 04102
Robert Kramer, MD207-662-2923Robert.Kramer@mainehealth.org

New Jersey

1 site
The Cooper Health System
Camden, New Jersey, 08103

New York

1 site
Columbia University
New York, New York, 10032
Aaron Mittel, MD212-305-9817am4656@cumc.columbia.edu

Pennsylvania

1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

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