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Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

NCT04754022 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1440

Last updated 2024-11-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • David Mazer, MD · Unity Health Toronto

  • Nadine Shehata, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • United States
  • Australia
  • Canada
  • Colombia
  • Egypt
  • Greece
  • India
  • Namibia
  • Nepal
  • Romania
  • Russia
  • Singapore
  • South Africa
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04754022 on ClinicalTrials.gov