Using patients' own blood to reduce transfusion needs after heart surgery
The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery (TheRAPy): a Multiple Period Vanguard Cluster Crossover Trial
This study is testing whether using patients' own blood during heart surgery can help reduce the need for blood transfusions compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 4500 (estimated) |
| Ages | 10 Years to 110 Years |
| Sex | All |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 4 sites (Winnipeg, Manitoba and 3 other locations) |
| Trial ID | NCT06230198 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the feasibility of implementing a routine practice of retrograde autologous priming (RAP) compared to traditional crystalloid priming during cardiac surgeries. By using patients' own blood to prime the heart-lung machine, the study aims to minimize red blood cell (RBC) loss and reduce the need for transfusions. Conducted across four hospitals, the trial will alternate between the two priming methods over 12 periods, involving approximately 4500 cardiac surgery patients. The results will inform whether a larger trial is warranted to confirm the benefits of RAP in reducing transfusion requirements.
Who should consider this trial
Good fit: Ideal candidates are adults undergoing cardiac surgery on cardiopulmonary bypass at participating hospitals.
Not a fit: Patients undergoing cardiac surgery at hospitals with fewer than 200 cases per year or where the surgical team does not agree to the trial protocols may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly decrease the need for RBC transfusions in cardiac surgery patients, improving patient outcomes and conserving blood resources.
How similar studies have performed: Previous smaller studies have shown that RAP can reduce RBC transfusions by significant margins, suggesting potential success for this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Hospitals completing \>200 adult cardiac surgical cases a year; (ii) 95% of cardiovascular surgery group (i.e., cardiac anesthesiologists, surgeons, and perfusionists) agree to manage patients under both autologous priming policies as per their randomization schedule for the duration of the trial. * All patients undergoing cardiac surgery on cardiopulmonary bypass at an enrolled site during the trial period will be included in data collection. Exclusion Criteria: * Complete \<=200 cardiac surgical cases. * \<95% of their cardiovascular surgery group agrees to manage patients according to either of the two policies.
Where this trial is running
Winnipeg, Manitoba and 3 other locations
- St. Boniface Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Jessica Spence, MD, PhD — Population Health Research Institute
- Study coordinator: TheRAPy Study Coordinator
- Email: therapy@phri.ca
- Phone: 9055212100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.