Comparing blood transfusion strategies in younger patients undergoing heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Maine Medical Center
  Portland, Maine, United States Recruiting
• The Cooper Health System
  Camden, New Jersey, United States Recruiting
• Royal Adelaide Hospital
  Adelaide, Adelaide, Australia Recruiting
• Royal Prince Alfred hospital
  Camperdown, New South Wales, Australia Recruiting
• Prince of Wales Hospital
  Randwick, New South Wales, Australia Recruiting
• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: David Mazer, MD — Unity Health Toronto
• Study coordinator: David Mazer, MD
• Email: David.Mazer@unityhealth.to
• Phone: 416-864-5825

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.