Personalized Blood Transfusion Protocol for Cardiac Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYan Mia Min
About this trial
This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.
Eligibility criteria
Qualifiers
Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures
Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)
Allogeneic red blood cell transfusion is considered likely
Able to provide informed consent and understand randomization to different transfusion thresholds
Disqualifiers
Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program
Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)
Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion
Off-pump bypass or other procedures not using cardiopulmonary bypass
Trial design
Treatments tested in this trial
- Demand-Informed Transfusion Decision Rule
Treatment groups
900 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov