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Aprotinin US Special Access Protocol

NCT00611845 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2014-06-23

No results posted yet for this study

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.

Conditions

  • Postoperative Hemorrhage

Interventions

DRUG

Aprotinin (Trasylol, BAYA0128)

Trasylol at either 1,000,000 KIU or 2,000,000 KIU

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611845 on ClinicalTrials.gov