Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery (TRICS-IV)

Unity Health Toronto

Status: Enrolling

Conditions: Cardiac Surgery; Heart; Disorder; Postoperative

Treatments: Other: Liberal transfusion strategy; Other: Restrictive Transfusion Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT04754022

TRICS-IV

Details and patient eligibility

About

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.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,440 participants in 2 patient groups

Restrictive Transfusion Strategy

Active Comparator group

Description:

Patients will receive a RBC transfusion if their Hb concentration is \<75 g/L (\<7.5 g/dL; \<4.7mmol/L) intraoperatively and/or postoperatively.

Treatment:

Other: Restrictive Transfusion Strategy

Liberal Transfusion Strategy

Active Comparator group

Description:

Patients will receive a RBC transfusion if their Hb concentration is \<95 g/L (\<9.5 g/dL; \<5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or \<85 g/L (\< 8.5 g/dL; \<5.3mmol/L) on the ward.

Treatment:

Other: Liberal transfusion strategy