RecruitingNot ApplicableNCT06230198

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

The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery (TheRAPy): a Multiple Period Vanguard Cluster Crossover Trial


Sponsor

Population Health Research Institute

Enrollment

4,500 participants

Start Date

Dec 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 110 Years

Inclusion Criteria2

  • 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 Criteria2

  • Complete <=200 cardiac surgical cases.
  • <95% of their cardiovascular surgery group agrees to manage patients according to either of the two policies.

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Interventions

PROCEDUREretrograde autologous priming (RAP)

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

PROCEDURECrystalloid priming

sites implement crystalloid priming use during cardiac surgery


Locations(4)

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Hamilton General Hospital

Hamilton, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Centre Hospitalier de l&#39;Université de Montréal (CHUM)

Montreal, Quebec, Canada

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NCT06230198