Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation
|ClinicalTrials.gov Identifier: NCT01596738|
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : May 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Coronary Artery Bypass Graft||Drug: Tranexamic Acid Drug: Saline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2012|
Experimental: Tranexamic Acid group
Drug: Tranexamic Acid
Placebo Comparator: Placebo group
- Allogeneic erythrocyte, volume transfused [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge
- Allogeneic erythrocyte, percentage exposed [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge
- Blood loss [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]The total volume of chest drainage from the end of the operation until the removal of the drainage tube
- Major bleeding [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]The incidence of major bleeding according to the CURE definition
- Reoperation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ]The incidence of reoperation for excessive bleeding
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596738
|Cardiovascular Institute and Fuwai Hospital|
|Beijing, China, 100037|
|Principal Investigator:||Lihuan Li, M.D.||Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS|