Red Blood Cell TransfusionTheRAPyNCT06230198
The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery
A study testing retrograde autologous priming (RAP) and Crystalloid priming in people with Red Blood Cell Transfusion, run by Population Health Research Institute at 4 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Red Blood Cell Transfusion
- What is being tested?
- retrograde autologous priming (RAP) and Crystalloid priming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 4 sitesCanada
- Study dates
- 4 Dec 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Complete <=200 cardiac surgical cases.
- <95% of their cardiovascular surgery group agrees to manage patients according to either of the two policies.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Spence contact
Canada4 sites, 4 recruiting
- Recruiting
Hamilton General Hospital
Hamilton, Ontario, L8S 48L
Courtney Mullen, 905-521-2100, Courtney.Mullen@phri.ca
Emilie Belley-Cote, Dr
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Alain Deschamps, Dr, a.deschamps@umontreal.ca
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
Julie Desroches, PhD, 514 890-8000 ext. 12172, julie.desroches.chum@ssss.gouv.qc.ca
Francois Martin Carrier, Dr.
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Dayna Solvason, 1 (204) 430-9815, dsolvason@sharedhealthmb.ca
Angela Recio, 1 (204) 430-9815, Angela.Recio@umanitoba.ca
About this study
Official title: 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.
Read the 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
- Being tested
- retrograde autologous priming (RAP), Crystalloid priming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrograde autologous priming (RAP)Procedure or surgery
sites follow an institutional policy of routine use of retrograde autologous priming (RAP) during cardiac surgery
Crystalloid primingProcedure or surgery
sites implement crystalloid priming use during cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Retrograde autologous priming | Experimental | sites implement retrograde autologous priming (RAP) during cardiac surgery Receives: Procedure: retrograde autologous priming (RAP) |
| Crystalloid priming | Experimental | sites implement crystalloid priming use during cardiac surgery Receives: Procedure: Crystalloid priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of implementing a full-scale randomized cluster crossover trial
Feasibility is defined as adherence >90% to both institutional policies applied in random sequence.
Measured: 6 months
Secondary outcomes (1)
Data Collection about Critical Parameters
to collect data about critical parameters that affect the design and implementation of the full-scale trial
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start4 Dec 2024
- Primary completionJan 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red Blood Cell TransfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a multiple period vanguard cluster crossover trial
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Spence, MD, PhD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230198
- Sponsor's protocol ID
- TheRAPy
- Acronym
- TheRAPy
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Retrograde Autologous Priming on Transfusion Requirements After Cardiac Surgery (TheRAPy): a Multiple Period Vanguard Cluster Crossover Trial
- ClinicalTrials.gov ID
- NCT06230198
- Acronym / sponsor ID
- TheRAPy / TheRAPy
- Conditions
- Red Blood Cell Transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a multiple period vanguard cluster crossover trial
| Arm | Type | Receives |
|---|---|---|
| Retrograde autologous priming | Experimental | Procedure: retrograde autologous priming (RAP)sites implement retrograde autologous priming (RAP) during cardiac surgery |
| Crystalloid priming | Experimental | Procedure: Crystalloid primingsites implement crystalloid priming use during cardiac surgery |
Who may qualify
- Ages
- 10 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Complete <=200 cardiac surgical cases.
- <95% of their cardiovascular surgery group agrees to manage patients according to either of the two policies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retrograde autologous priming (RAP)sites follow an institutional policy of routine use of retrograde autologous priming (RAP) during cardiac surgery | Procedure or surgery | Retrograde autologous priming |
| Crystalloid primingsites implement crystalloid priming use during cardiac surgery | Procedure or surgery | Crystalloid priming |
Primary outcome
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.
1 secondary outcome
Data Collection about Critical Parameters
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Spence contact
Jessica Spence, MD, PhD principal investigator
Population Health Research Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retrograde autologous priming (RAP) and Crystalloid priming in people with Red Blood Cell Transfusion, run by Population Health Research Institute at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TheRAPy Study Coordinator (9055212100, therapy@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of implementing a full-scale randomized cluster crossover trial (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.