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

NCT ID: NCT06230198

Last Updated: 2025-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-04
• Study Completion Date: 2026-11-30

Brief 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.

Detailed Description

About 50% of patients undergoing cardiac surgery require red blood cell (RBC) transfusion. Given the limited blood supply and harms of transfusion, evidence-based blood conservation strategies are a priority. There is one such simple conservation technique called Retrograde autologous priming (RAP), in which the patient's own blood, rather than crystalloid fluid, is used to prime the heart-lung machine. Ultimately, it minimizes the loss of RBCs during surgery. Despite evidence of RAP reducing incidence of RBC transfusions by 40% and RBC units transfused by 38% in small randomized trials, it is not routinely used due to the uncertainty about overall benefit and potential harms. Routine RAP may be beneficial, but this needs to be confirmed in a large pragmatic randomized trial. Therefore, the goal of this vanguard trial is to assess the feasibility of a full-scale multi-centre randomized cluster crossover trial to determine whether an institutional policy of routine RAP reduces the number of RBC units transfused up to 72 hours after cardiac surgery compared to crystalloid priming. This will include 4 sites that will test the two policies in an alternating sequence during 12 periods of 4 weeks, with an expected volume of 4500 cardiac surgery patients. If the adherence to both polices is >=90%, a full trial will be conducted. The findings of this study have the potential to improve the outcomes of tens of thousands of patients around the world and will provide the basis for cardiac practice guidelines.

Conditions

Red Blood Cell Transfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Retrograde autologous priming

sites implement retrograde autologous priming (RAP) during cardiac surgery

Group Type: EXPERIMENTAL

retrograde autologous priming (RAP)

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Crystalloid priming

Intervention Type: PROCEDURE

sites implement crystalloid priming use during cardiac surgery

Interventions

retrograde autologous priming (RAP)

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

Intervention Type: PROCEDURE

Crystalloid priming

sites implement crystalloid priming use during cardiac surgery

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Spence, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Hamilton General Hospital

Hamilton, Ontario, Canada

Site Status: RECRUITING

Montreal Heart Institute

Montreal, Quebec, Canada

Site Status: RECRUITING

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

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

TheRAPy Study Coordinator

Role: CONTACT

therapy@phri.ca

9055212100

Jessica Spence

Role: CONTACT

Facility Contacts

Dayna Solvason

Role: primary

dsolvason@sharedhealthmb.ca

1 (204) 430-9815

Angela Recio

Role: backup

Angela.Recio@umanitoba.ca

1 (204) 430-9815

Courtney Mullen

Role: primary

Courtney.Mullen@phri.ca

905-521-2100

Alain Deschamps, Dr

Role: primary

a.deschamps@umontreal.ca

Julie Desroches, PhD

Role: primary

julie.desroches.chum@ssss.gouv.qc.ca

514 890-8000 ext. 12172

Other Identifiers

TheRAPy

Identifier Type: -

Identifier Source: org_study_id