Heart Diseases Clinical Trial
Official title:
Blood Conservation in Cardiac Surgery Using a Novel Transfusion Algorithm Based on Point-of-care Testing-A Stepped-wedge Cluster Randomized Controlled Trial
This multi-centre study will provide sound, generalizable data on the effectiveness of a
POC-based algorithm to determine to what extent this guideline can reduce blood product
transfusions. Investigators will study outcomes in 7000 patients undergoing heart surgery at
10 participating hospitals. The proposed trial addresses several important research and
clinical issues and has the potential to markedly improve the transfusion management and
surgical care in general of cardiac surgery patients.
The intervention will be a novel POC-based algorithm that has been shown in a pilot study by
us to be associated with a substantial reduction in blood product transfusions. The
algorithm will employ viscoelastic and aggregometric POC-tests and an objective measure of
blood loss. The primary outcome will be avoidance of red blood cell transfusion during
hospitalization. The study has a 90% power to detect a 12% increase in avoidance rate.
Secondary outcomes will include avoidance of red blood cell use and other blood products
(plasma, platelets, and cryoprecipitate), units of blood products transfused, and adverse
clinical outcomes related to transfusion (acute kidney injury, infections, and death). Data
will also be collected for future health-economics analyses.
Largely due to the limitations of existing evidence, however, such algorithms are rarely
used in clinical practice. The proposed trial will provide sound, generalizable data on the
effectiveness of a POC-based algorithm to guide their future use. An integrated blood
management algorithm that employs POC coagulation tests will reduce blood product
transfusions in cardiac surgery, thereby improving clinical outcomes.
Does an integrated blood transfusion algorithm that employs POC coagulation tests applied
across a network of hospitals reduce blood transfusions and associated adverse outcomes in
cardiac surgery?
Despite major advances in cardiac surgery, coagulopathy continues to carry a heavy burden in cases that require the use of cardiopulmonary bypass (CPB), occurring frequently and resulting in excessive blood loss, blood product transfusions, and adverse clinical outcomes. Current management of coagulopathy is hampered by the inability of conventional laboratory tests to delineate its etiology in a timely manner, thereby precluding timely and targeted transfusion therapy. With the advent of point-of-care (POC) coagulation tests that can rapidly identify the etiology of coagulopathy, it may now be possible to reduce the burden of coagulopathy and thereby reduce transfusions and adverse outcomes. Several single-centre studies (including one by the investigator group) have found that the use of POC-based algorithms in cardiac surgery can markedly reduce blood product transfusions and by that means reduce morbidities and mortality. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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