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Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving Antiplatelet Therapy With Clopidogrel (Plavix)

This study is currently recruiting participants.
Verified by Rikshospitalet-Radiumhospitalet HF, November 2005

Sponsored by: Rikshospitalet-Radiumhospitalet HF
Information provided by: Rikshospitalet-Radiumhospitalet HF
ClinicalTrials.gov Identifier: NCT00257751
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Aprotinine

MedlinePlus related topics:   Coronary Artery Disease   

ChemIDplus related topics:   Aprotinin    Clopidogrel    Clopidogrel Bisulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Official Title:   Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving

Further study details as provided by Rikshospitalet-Radiumhospitalet HF:

Primary Outcome Measures:
  • Perioperative bleeding
  • Blood transfusions
  • Reoperation

Secondary Outcome Measures:
  • Costs

Estimated Enrollment:   400
Study Start Date:   March 2004
Estimated Study Completion Date:   March 2007

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

All coronary bypass operations in patients receiving Plavix within the last 7 days

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257751

Contacts
Contact: Eivind Øvrum, MD, PhD     +4722866500     eivind.ovrum@hjertesenteret.no    

Locations
Norway
RRHF     Recruiting
      Oslo, Norway, 0027
      Contact: Eivind Øvrum, MD, PhD     +4722866500     eivind.ovrum@hjertesenteret.no    

Sponsors and Collaborators
Rikshospitalet-Radiumhospitalet HF

Investigators
Principal Investigator:     Eivind Øvrum, MD, PhD     Rikshospitalet-Radiumhospitalet HF    
  More Information


Study ID Numbers:   APROT04, APROT04
First Received:   November 22, 2005
Last Updated:   November 22, 2005
ClinicalTrials.gov Identifier:   NCT00257751
Health Authority:   Norway: Norwegian Medicines Agency;   Norway:The Data Inspectorate;   Norway: Directorate for Health and Social Affairs

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clopidogrel
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease
Aprotinin

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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