Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00257751
First received: November 22, 2005
Last updated: July 3, 2011
Last verified: March 2009
History of Changes
  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

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

Resource links provided by NLM:

Drug Information available for: Aprotinin
U.S. FDA Resources

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.

  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

Sponsors and Collaborators
Oslo University Hospital
Investigators
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
ClinicalTrials.gov 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
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aprotinin
Trypsin Inhibitors
 Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013