Aprotinin US Special Access Protocol

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

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.

Study Overview

• Status: No longer available
• Conditions: Postoperative Hemorrhage
• Intervention / Treatment: Drug: Aprotinin (Trasylol, BAYA0128)

• Study Type: Expanded Access

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Registration Dates

• First Submitted: January 29, 2008
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 20, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Hemostatics; Coagulants; Trypsin Inhibitors; Aprotinin
• Other Study ID Numbers: 13087