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

NCT06230198 | Recruiting

• 1 other identifier: TheRAPy
• Study Type: interventional
• Target: 4,500
• Locations: 1 country
• Sites: 4

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.

Conditions

Red Blood Cell Transfusion

Outcome Measures

Primary Outcomes (1)

• Feasibility of implementing a full-scale randomized cluster crossover trial

  Feasibility is defined as adherence \>90% to both institutional policies applied in random sequence.

  6 months

Secondary Outcomes (1)

• Data Collection about Critical Parameters

  6 months

Study Arms (2)

Retrograde autologous priming

EXPERIMENTAL

sites implement retrograde autologous priming (RAP) during cardiac surgery

Procedure: retrograde autologous priming (RAP)

Crystalloid priming

EXPERIMENTAL

sites implement crystalloid priming use during cardiac surgery

Procedure: Crystalloid priming

Interventions

retrograde autologous priming (RAP) PROCEDURE

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

Retrograde autologous priming

Crystalloid priming PROCEDURE

sites implement crystalloid priming use during cardiac surgery

Crystalloid priming

Eligibility Criteria

• Age: 10 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (4)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

RECRUITING

Hamilton General Hospital

Hamilton, Ontario, L8S 48L, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

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

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

Study Officials

• Jessica Spence, MD, PhD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TheRAPy Study Coordinator

CONTACT

9055212100; therapy@phri.ca

Jessica Spence

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a multiple period vanguard cluster crossover trial

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 30, 2024
• Study Start: December 4, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)