Back to resultsDifferent Regimen of Aprotinine(Trasylol) Administration in Patients Receiving Antiplatelet Therapy With Clopidogrel (Plavix)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aprotinine
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
All coronary bypass operations in patients receiving Plavix within the last 7 days
Sites / Locations
Outcomes
Primary Outcome Measures
Perioperative bleeding
Blood transfusions
Reoperation
Secondary Outcome Measures
Difference in costs related to low/high dose
Full Information
NCT ID
NCT00257751
First Posted
November 22, 2005
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00257751
Brief Title
Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving Antiplatelet Therapy With Clopidogrel (Plavix)
Official Title
Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clopidogrel (Plavix), a platelet ADP receptor antagonist, has become the standard of care to prevent thrombosis in interventional cardiology and is increasingly being used in unstable angina and NSTEMI. An increasing number of patients are referred to emergent or urgent CABG, and several studies, as well as our own experience, have shown that preoperative administration of irreversible platelets inhibitors increase the risk of bleeding complications following CABG.
Detailed Description
Aprotinine (Trasylol) is a potent antifibrinolytic agent known to reduce bleeding after cardiac surgery. The most commeon practice is to give Trasylol in high doses immediately before surgery, during the operation, and during the first postoperative hours. However, it has also been shown that there is a hemostatic effect of the drug when given in a lower dose postoperatively, but this remains unclear.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Aprotinine
Primary Outcome Measure Information:
Title
Perioperative bleeding
Title
Blood transfusions
Title
Reoperation
Secondary Outcome Measure Information:
Title
Difference in costs related to low/high dose
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
All coronary bypass operations in patients receiving Plavix within the last 7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eivind Øvrum, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving Antiplatelet Therapy With Clopidogrel (Plavix)
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