Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

Part of paid clinical trials in Portland, Maine.

Sponsor
Unity Health Toronto
Study ID
NCT04754022
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Surgery
  • Disorder
  • Heart
  • Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Restrictive Transfusion Strategy — OTHER
    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.
  • Liberal transfusion strategy — OTHER
    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.

Study Details

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.

Key Dates

Start date
Nov 1, 2021
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
1,440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). [ Time Frame: Within 6 months after cardiac surgery. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Maine Medical CenterPortlandMaine04102
Robert Kramer, MD
[email protected]
207-662-2923
Robert Kramer, MD
The Cooper Health SystemCamdenNew Jersey08103
Ludmil Mitrev, MD
[email protected]
Ludmil Mitrev, MD
Columbia UniversityNew YorkNew York10032
Aaron Mittel, MD
[email protected]
212-305-9817
Aaron Mittel, MD
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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By research site
Maine Medical Center· Portland, METhe Cooper Health System· Camden, NJColumbia University· New York, NYThomas Jefferson University· Philadelphia, PA

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