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.
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.
Complete <=200 cardiac surgical cases.
<95% of their cardiovascular surgery group agrees to manage patients according to either of the two policies.
Crossover
retrograde autologous priming (RAP)
Procedure/Surgerysites follow an institutional policy of routine use of retrograde autologous priming (RAP) during cardiac surgery
Crystalloid priming
Procedure/Surgerysites implement crystalloid priming use during cardiac surgery
Feasibility of implementing a full-scale randomized cluster crossover trial
Feasibility is defined as adherence \>90% to both institutional policies applied in random sequence.
Data Collection about Critical Parameters
to collect data about critical parameters that affect the design and implementation of the full-scale trial
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