Aprotinin US Special Access Protocol
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Hemorrhage
Intervention: Aprotinin (Trasylol, BAYA0128) (Drug)
Status: No longer available
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
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.
Official title: Aprotinin US Special Access Protocol: An Open Label, Non-Comparative Treatment Protocol for the Use of Aprotinin in Patients Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass Who Are at Increased Risk of Blood Loss and Transfusion
Study design: N/A
Minimum age: 18 Years.
Maximum age: N/A.
- 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,
- 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
- Patients undergoing primary CABG with advanced age or multiple comorbidities
such as preoperative anemia, coagulopathies, diabetes mellitus, and peripheral
- 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
- 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
- Patients with a known or suspected allergy to aprotinin.
Locations and Contacts
Decatur, Alabama 35601, United States
Glendale, California 91206, United States
Pismo Beach, California 93449, United States
Santa Monica, California 90404, United States
Ventura, California 93003, United States
Fort Wayne, Indiana 46804, United States
Edgewood, Kentucky 41017, United States
New Brunswick, New Jersey 08903, United States
Asheville, North Carolina 28805, United States
Medford, Oregon 97504, United States
Portland, Oregon 97210, United States
Portland, Oregon 97225, United States
Philadelphia, Pennsylvania 19107, United States
Knoxville, Tennessee 37917, United States
Lynchburg, Virginia 24501, United States
Milwaukee, Wisconsin 53215, United States
Wausau, Wisconsin 54401, United States
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Last updated: June 20, 2014