Home › Trials › NCT04754022

Comparing blood transfusion strategies in younger patients undergoing heart surgery

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

Not applicable Interventional Unity Health Toronto · NCT04754022

This study tests which blood transfusion method works better for younger patients having heart surgery to help them recover more smoothly and avoid complications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1440 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorUnity Health Toronto Academic / other
Locations54 sites (Portland, Maine and 53 other locations)
Trial IDNCT04754022 on ClinicalTrials.gov

What this trial studies

This trial evaluates two blood transfusion strategies—restrictive and liberal—in patients aged 65 and younger who are at moderate to high risk undergoing cardiac surgery with cardiopulmonary bypass. It is an international, multi-centre, open-label randomized controlled trial designed to determine which strategy is more effective. The study aims to improve postoperative outcomes by assessing the impact of these transfusion approaches on recovery and complications. Participants will be randomly assigned to one of the two transfusion strategies to compare their effects.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18 to 65 who are scheduled for cardiac surgery using cardiopulmonary bypass and have a EuroSCORE I of 6 or more.

Not a fit: Patients who refuse blood products, are pregnant or lactating, or are undergoing heart transplants will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complications for younger patients undergoing cardiac surgery.

How similar studies have performed: Previous studies have shown varying success with transfusion strategies in cardiac surgery, but this specific approach in younger patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Portland, Maine and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions DisorderHeartPostoperativeCardiac SurgeryTransfusion
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.