Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding in Coronary Surgical Patients (ICARE)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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.|
- chest blood output during the first 24 hours [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
group treated with aspirin alone
Goup treated with aspirin and clopidogrel
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216150
|Hopital Pitié Salpêtrière|
|Paris, France, 75013|
|Study Director:||Julien Amour, MD.PhD||Groupe Hospitalier Pitie-Salpetriere|