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

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ClinicalTrials.gov Identifier: NCT00257751
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Aprotinine Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving
Study Start Date : March 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Perioperative bleeding
  2. Blood transfusions
  3. Reoperation

Secondary Outcome Measures :
  1. Difference in costs related to low/high dose


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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

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

Responsible Party: Eivind Øvrum, MD, PhD, Oslo Heart Center, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00257751     History of Changes
Other Study ID Numbers: APROT04
APROT04
First Posted: November 23, 2005    Key Record Dates
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