Status:
NO_LONGER_AVAILABLE
Aprotinin US Special Access Protocol
Lead Sponsor:
Bayer
Conditions:
Postoperative Hemorrhage
Eligibility:
All Genders
18+ years
Brief 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 underg...
Eligibility Criteria
Inclusion
- Patients 18 years of age and older
- Patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. These patients may include the following:
- Patients receiving preoperative antithrombotic drugs (e.g., clopidogrel, aspirin),
- Patients undergoing repeat CABG or complex CABG procedures,
- Patients undergoing urgent or emergent CABG procedures,
- Patients who refuse to receive allogeneic blood products for religious or other reasons,
- Patients undergoing primary CABG with advanced age or multiple comorbidities such as preoperative anemia, coagulopathies, diabetes mellitus, and peripheral vascular disease
- The physician has determined that no acceptable alternative comparable therapy is available for the patient and that there is a clearly favorable benefit-risk for the drug in that individual patient
- Documented, signed, dated informed consent obtained prior to entry into the study
Exclusion
- Patients with a known or suspected previous aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products, and the use of these products should be considered when evaluating previous aprotinin exposure
- Patients with a known or suspected allergy to aprotinin.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00611845
Last Update
June 23 2014
Active Locations (17)
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1
Decatur, Alabama, United States, 35601
2
Glendale, California, United States, 91206
3
Pismo Beach, California, United States, 93449
4
Santa Monica, California, United States, 90404