Aprotinin US Special Access Protocol
1 other identifier
expanded_access
N/A
1 country
17
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedJune 23, 2014
June 1, 2014
January 29, 2008
June 20, 2014
Conditions
Keywords
Interventions
Trasylol at either 1,000,000 KIU or 2,000,000 KIU
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (17)
Unknown Facility
Decatur, Alabama, 35601, United States
Unknown Facility
Glendale, California, 91206, United States
Unknown Facility
Pismo Beach, California, 93449, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Ventura, California, 93003, United States
Unknown Facility
Fort Wayne, Indiana, 46804, United States
Unknown Facility
Edgewood, Kentucky, 41017, United States
Unknown Facility
New Brunswick, New Jersey, 08903, United States
Unknown Facility
Asheville, North Carolina, 28805, United States
Unknown Facility
Medford, Oregon, 97504, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Portland, Oregon, 97225, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Knoxville, Tennessee, 37917, United States
Unknown Facility
Lynchburg, Virginia, 24501, United States
Unknown Facility
Milwaukee, Wisconsin, 53215, United States
Unknown Facility
Wausau, Wisconsin, 54401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 29, 2008
First Posted
February 11, 2008
Last Updated
June 23, 2014
Record last verified: 2014-06