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

February 27, 2025 updated by: Population Health Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

4500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: TheRAPy Study Coordinator
  • Phone Number: 9055212100
  • Email: therapy@phri.ca

Study Contact Backup

  • Name: Jessica Spence

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
    • Ontario
      • Hamilton, Ontario, Canada, L8S 48L
        • Recruiting
        • Hamilton General Hospital
        • Contact:
        • Contact:
          • Emilie Belley-Cote, Dr
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Contact:
        • Contact:
          • Francois Martin Carrier, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retrograde autologous priming
sites implement retrograde autologous priming (RAP) during cardiac surgery
Procedure: retrograde autologous priming (RAP)
sites follow an institutional policy of routine use of retrograde autologous priming (RAP) during cardiac surgery
Experimental: Crystalloid priming
sites implement crystalloid priming use during cardiac surgery
Procedure: Crystalloid priming
sites implement crystalloid priming use during cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of implementing a full-scale randomized cluster crossover trial
Time Frame: 6 months
Feasibility is defined as adherence >90% to both institutional policies applied in random sequence.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data Collection about Critical Parameters
Time Frame: 6 months
to collect data about critical parameters that affect the design and implementation of the full-scale trial
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Jessica Spence, MD, PhD, Population Health Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 23, 2023

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TheRAPy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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