Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding in Coronary Surgical Patients (ICARE)
|ClinicalTrials.gov Identifier: NCT01216150|
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : June 23, 2011
Aims Aspirin combined with clopidogrel is the treatment of choice for acute coronary syndromes. Although the maintenance of aspirin until surgery does not affect postoperative bleeding after coronary artery bypass graft (CABG) surgery, the latter may be dramatically increased when clopidogrel is continued over a period of 5 days preoperatively. Methods and results: This prospective observational study will include 136 consecutive patients scheduled for first-time CABG. Postoperative bleeding and blood transfusion requirements will be compared (non inferiority)between patients pretreated during a period of 5 days prior surgery by either aspirin alone or combined with clopidogrel. Tranexamic acid will be systematically used in all these patients considered as high risk for bleeding.
In concusion, this study has to to test the hypothesis that with tranexamic acid also, bleeding in the aspirin + clopidogrel group is not 25% more important than in the aspirin alone group after CABG surgery, according to the previous study using aprotinin.
|Condition or disease|
|Coronary Surgery Hemorrhage|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding and Platelets Functions in Coronary Surgical Patients Treated Prophylactically With Tranexamic Acid: the ICARE Study.|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
group treated with aspirin alone
Goup treated with aspirin and clopidogrel
- chest blood output during the first 24 hours [ Time Frame: 24 hours postoperative ]Chest blood collected through chest tubes during the first 24 postoperative hours.
- the rate of re-exploration for excessive bleeding, transfusion requirement, prolonged mechanical ventilation (>10 h), and intensive care unit length of stay (>72 h). [ Time Frame: During critical care unit hospitalisation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01216150
|Hopital Pitié Salpêtrière|
|Paris, France, 75013|
|Study Director:||Julien Amour, MD.PhD||Groupe Hospitalier Pitie-Salpetriere|