Study Completed

Postoperative Hemorrhage

Bayer Identifier:

13087

ClinicalTrials.gov Identifier:

NCT00611845

EudraCT Number:

Not Available

EU CT Number:

Not Available

Aprotinin US Special Access Protocol

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years

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.

Trial summary

Enrollment Goal

N/A

Trial Dates

null - Today

Phase

N/A

Could I Receive a placebo

Products

Trasylol (Aprotinin, BAYA0128)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Community Memorial Hospital	Ventura, 93003, United States
Completed	Providence St.Vincent Medical Center	Portland, 97225, United States
Completed	Indiana/Ohio Heart	Fort Wayne, 46804, United States
Terminated	Legacy Emanuel Hospital & Health Center	Portland, 97210, United States
Completed	Saint Mary's Medical Center	Knoxville, 37917, United States
Completed	Charles George VA Medical Center	Asheville, 28805, United States
Completed	Central Coast Cardiothoracic Surgical Associates	Pismo Beach, 93449, United States
Completed	Decatur Cardiovascular Surgery	Decatur, 35601, United States
Completed	Aspirus Wausau Hospital	Wausau, 54401, United States
Completed	Office of Dr. Michael Savitt, MD	Milwaukee, 53215, United States
Completed	Robert Wood Johnson University Hospital	New Brunswick, 08903, United States
Completed	Providence Medford Medical Center	Medford, 97504, United States
Completed	Saint John's Health Center	Santa Monica, 90404, United States
Completed	Centra Health Cardiovascular Group	Lynchburg, 24501, United States
Completed	Thomas Jefferson University	Philadelphia, 19107, United States
Completed	Glendale Adventist Medical Center	Glendale, 91206, United States
Completed	St. Elizabeth Medical Center - Edgewood	Edgewood, 41017, United States

Trial design

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

Trial Type

Expanded Access

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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