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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00257751
First Posted: November 23, 2005
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving

Resource links provided by NLM:


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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
All coronary bypass operations in patients receiving Plavix within the last 7 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257751


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

Responsible Party: Eivind Øvrum, MD, PhD, Oslo Heart Center, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00257751     History of Changes
Other Study ID Numbers: APROT04
First Submitted: November 22, 2005
First Posted: November 23, 2005
Last Update Posted: July 6, 2011
Last Verified: March 2009

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aprotinin
Hemostatics
Coagulants
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action