drugset / Trial / NCT00611845

Aprotinin US Special Access Protocol

NCT00611845

Expanded access No longer available Bayer

Summary

This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprotinin Unknown 1e+06 unknown
Subject Aprotinin Unknown 2e+06 unknown

Indications

No indication recorded.