Coronary Artery Disease Clinical Trial
Official title:
Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion
The use of platelet aggregation inhibitors, including aspirin and clopidogrel, has become a
standard management strategy for patients with acute coronary syndrome. On this background,
an increasing percentage of patients presenting for surgical coronary revascularization is
the subject to irreversible platelet inhibition.
Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for
aprotinin when the latter has been suspended in 2007.The release of plasmin during CPB
activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological
inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and
fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin
formation and inhibits fibrinolysis.
Many studies and meta-analyses have shown a reduction in postoperative bleeding and
transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery.
Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few
studies specify the time between the last clopidogrel ingestion and surgery.Several studies
were keen on the blood loss and allogeneic transfusion in patients who received their last
clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the
secession of aprotinin and the increasing proportion of patients with persistence on
clopidogrel until their surgery, evolutional work is expected, especially in the eastern
population.
The purpose of this study is to assess the effect of tranexamic acid in patients with
clopidogrel and asprin ingestion less than 7 days prior to surgery. The working hypothesis
is that tranexamic acid would reduce bleeding and transfusion requirements in this specific
population of patients.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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