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Aprotinin US Special Access Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00611845
Expanded Access Status : No longer available
First Posted : February 11, 2008
Last Update Posted : June 23, 2014
Information provided by:

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.

Condition or disease Intervention/treatment
Postoperative Hemorrhage Drug: Aprotinin (Trasylol, BAYA0128)

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Study Type : Expanded Access
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Aprotinin

Intervention Details:
  • Drug: Aprotinin (Trasylol, BAYA0128)
    Trasylol at either 1,000,000 KIU or 2,000,000 KIU

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00611845

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United States, Alabama
Decatur, Alabama, United States, 35601
United States, California
Glendale, California, United States, 91206
Pismo Beach, California, United States, 93449
Santa Monica, California, United States, 90404
Ventura, California, United States, 93003
United States, Indiana
Fort Wayne, Indiana, United States, 46804
United States, Kentucky
Edgewood, Kentucky, United States, 41017
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, North Carolina
Asheville, North Carolina, United States, 28805
United States, Oregon
Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97210
Portland, Oregon, United States, 97225
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Knoxville, Tennessee, United States, 37917
United States, Virginia
Lynchburg, Virginia, United States, 24501
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53215
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG Identifier: NCT00611845     History of Changes
Other Study ID Numbers: 13087
First Posted: February 11, 2008    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Bayer:
CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion
Additional relevant MeSH terms:
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Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action