Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Oslo University Hospital Identifier:
First received: November 22, 2005
Last updated: July 3, 2011
Last verified: March 2009

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving

Further study details as provided by Oslo University Hospital:

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

Secondary Outcome Measures:
  • Difference in costs related to low/high dose [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: March 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00257751

Sponsors and Collaborators
Oslo University Hospital
Principal Investigator: Eivind Øvrum, MD, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: Eivind Øvrum, MD, PhD, Oslo Heart Center, Rikshospitalet HF Identifier: NCT00257751     History of Changes
Other Study ID Numbers: APROT04, APROT04
Study First Received: November 22, 2005
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency
Norway: Data Protection Authority
Norway: Directorate of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on November 20, 2014