ClinicalTrials.Veeva

Menu

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

U

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

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

Trial contacts and locations

54

Loading...

Central trial contact

David Mazer, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems