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NCT Number: NCT06230198

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

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.

Recruiting

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Key information

Age range

10 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Boniface Hospital, Winnipeg, Manitoba, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

retrograde autologous priming (RAP)

Procedure

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

Crystalloid priming

Procedure

sites implement crystalloid priming use during cardiac surgery

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Spence

CONTACT

TheRAPy Study Coordinator

CONTACT

[email protected]

9055212100

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: TheRAPy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2024
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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