Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06230198 |
Other study ID # |
TheRAPy |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2024 |
Est. completion date |
March 2025 |
Study information
Verified date |
January 2024 |
Source |
Population Health Research Institute |
Contact |
TheRAPy Study Coordinator |
Phone |
9055212100 |
Email |
therapy[@]phri.ca |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 on cardiopulmonary bypass. It will also
provide information about key parameters of the TheRAPy full-scale trial.
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.