Health Trials

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

ConditionsDisorderHeartPostoperativeCardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUnity Health Toronto

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 and ≤65 years of age

Planned cardiac surgery using cardiopulmonary bypass

Informed consent obtained

Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Disqualifiers

Patients who refuse participation

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Restrictive Transfusion Strategy

    Other intervention

    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 intervention

    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 groups

1,440 Participants
are divided into 2 treatment groups
Group A: Restrictive Transfusion StrategyActive comparator 1 intervention
Group B: Liberal Transfusion StrategyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).

Time frame
Within 6 months after cardiac surgery.

Secondary outcomes

1

Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

Time frame
Within 6 months after cardiac surgery.
2

Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

Time frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
3

Length of stay in the ICU and hospital.

Length of stay in the ICU and hospital in days.

Time frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.
4

Prolonged low output state.

Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively.

Time frame
Up to hospital discharge or after 28 days postoperatively, whichever comes first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Unity Health Toronto

Lead sponsor

Source ClinicalTrials.gov
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