Impact of Combination of Clopidogrel With Aspirin on Postoperative Bleeding in Coronary Surgical Patients

NCT01216150 | Completed

• 1 other identifier: ICARE Study
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Surgery; Hemorrhage

Keywords

antifibrinolytic drug; coronary surgery; hemorrhage; aspirin; clopidogrel

Outcome Measures

Primary Outcomes (1)

• chest blood output during the first 24 hours

  Chest blood collected through chest tubes during the first 24 postoperative hours.

  24 hours postoperative

Secondary Outcomes (1)

• the rate of re-exploration for excessive bleeding, transfusion requirement, prolonged mechanical ventilation (>10 h), and intensive care unit length of stay (>72 h).

  During critical care unit hospitalisation

Study Arms (2)

aspirin

group treated with aspirin alone

aspirin clopidogrel

Goup treated with aspirin and clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

During the planned 11 months of investigation, all patients undergoing isolated first-time coronary artery by-pass grafting will be enrolled. Patients admitted for emergency procedure, following failed percutaneous transluminal coronary angioplasty and off-pump coronary surgery, will be excluded. Because antithrombotic therapy management may differ during the postoperative period, we will exclude patients in whom a mechanical support or intra-aortic balloon pump will be required for a difficult weaning from cardiopulmonary bypass. Finally, we will exclude all patients who will not have received any oral antiplatelet agents within 5 days prior surgery, those who will have been preoperatively exposed to platelet glycoprotein IIb/IIIa inhibitors, and those with history of haematological disease. Patients treated with aspirin and clopidogrel and in whom clopidogrel will be stopped more than 5 days before surgery will also be excluded.

You may qualify if:

• all patients undergoing isolated first-time coronary artery by-pass grafting will be enrolled.

You may not qualify if:

• patient who do not want to be include
• pregnant
• patient \< 18 yrs old
• emergency procedure with failed percutaneous transluminal coronary angioplasty
• off-pump coronary surgery
• patients in whom a mechanical support (ECMO) or intra-aortic balloon pump will be required for a difficult weaning from cardiopulmonary bypass
• patients who will not have received any oral antiplatelet agents within 5 days prior surgery
• patient who will be preoperatively exposed to platelet glycoprotein IIb/IIIa inhibitors
• Patients treated with aspirin and clopidogrel and in whom clopidogrel will be stopped more than 5 days before surgery

Sponsors & Collaborators

• Groupe Hospitalier Pitie-Salpetriere: lead

Study Sites (1)

Hopital Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien Amour, MD.PhD

  Groupe Hospitalier Pitie-Salpetriere

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 23, 2011

Record last verified: 2010-10

Locations

FR (1)