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

Sponsor:	Rikshospitalet HF
Information provided by:	Rikshospitalet 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

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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

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

Rikshospitalet HF

Investigators

Principal Investigator:

Eivind Øvrum, MD, PhD

Rikshospitalet HF

More Information

No publications provided

Responsible Party:	Oslo Heart Center, Rikshospitalet HF ( Eivind Øvrum, MD, PhD )
Study ID Numbers:	APROT04, APROT04
Study First Received:	November 22, 2005
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00257751 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency; Norway: Data Inspectorate; Norway: Directorate for Health and Social Affairs

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 08, 2010