NCT04754022

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,440 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disorder
• Heart
• Postoperative
• Cardiac Surgery

Interventions

Type	Name	Description
OTHER	Restrictive Transfusion Strategy	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.
OTHER	Liberal transfusion strategy	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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2021-02-15
• Last updated: 2024-11-21

Locations

54 sites across 16 countries: United States, Australia, Canada, Colombia, Egypt, Greece, India, Namibia, Nepal, Romania, Russia, Singapore, South Africa, Spain, Switzerland, United Kingdom