The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery

NCT06230198 · tracked via the Priya Life Science Canada tracker

Sponsor

Population Health Research Institute

Phase

Not applicable

Started

2024-12-04

Last updated

2025-03-04

Condition(s) studied

Red Blood Cell Transfusion

Investigational drug(s) / intervention(s)

retrograde autologous priming (RAP)Crystalloid priming

retrograde autologous priming (RAP): sites follow an institutional policy of routine use of retrograde autologous priming (RAP) during cardiac surgery

Crystalloid priming: sites implement crystalloid priming use during cardiac surgery

Study summary

The TheRAPy vanguard trial is a multicentre, multiple period randomized, cluster crossover vanguard trial testing the feasibility of a full-scale trial to evaluate whether a centre-based policy of routine use of RAP versus a policy of crystalloid priming reduces RBC transfusion for patients undergoing cardiac surgery on cardiopulmonary bypass. It will also provide information about key parameters of the TheRAPy full-scale trial.

Eligibility

Sex

ALL

Min age

10 Years

Max age

110 Years

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Feasibility of implementing a full-scale randomized cluster crossover trial — 6 months
Feasibility is defined as adherence \>90% to both institutional policies applied in random sequence.

Trial sites (4)

Facility	City	Region	Status
St. Boniface Hospital	Winnipeg	Manitoba	Recruiting
Hamilton General Hospital	Hamilton	Ontario	Recruiting
Montreal Heart Institute	Montreal	Quebec	Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec	Recruiting

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Living Green and Healthy for Teens Active, not recruiting

Other trials for the same condition

Trial of Indication-Based Transfusion of Red Blood Cells in ECMO Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06230198 on ClinicalTrials.gov ↗ ← All trials in Canada