Transfusion Requirements in Cardiac Surgery III (TRICS-III)

Unity Health Toronto

Status: Completed

Conditions: Disorder; Heart, Functional, Postoperative, Cardiac Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02042898

TRICSIII

301852 (Other Grant/Funding Number)

Details and patient eligibility

About

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

Enrollment: 5,028 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Planned cardiac surgery using cardiopulmonary bypass
• Informed consent obtained
• Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion criteria

• 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.)
• Patients who are unable to receive or who refuse blood products

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,028 participants in 2 patient groups

Restrictive transfusion strategy

Active Comparator group

Description:

Restrictive transfusion strategy: patients will receive a red cell transfusion if their hemoglobin 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:

Liberal transfusion strategy: patients will receive a red cell transfusion if their hemoglobin concentration is \<95 g/L (\<9.5 g/dL\<5.9mmol/L) intraoperatively, or postoperatively in the intensive care unit; and/or \<85 g/L (\< 8.5 g/dL;\<5.3mmol/L) on the ward.

Treatment:

Other: Liberal transfusion strategy