Aprotinin US Special Access Protocol

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00611845
First received: January 29, 2008
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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 Intervention
Postoperative Hemorrhage
Drug: Aprotinin (Trasylol, BAYA0128)

Study Type: Expanded Access     What is 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 NLM:


Further study details as provided by Bayer:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611845

Locations
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00611845     History of Changes
Other Study ID Numbers: 13087
Study First Received: January 29, 2008
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion

Additional relevant MeSH terms:
Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Aprotinin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014