Trial Condition(s):

Postoperative Hemorrhage

Aprotinin US Special Access Protocol

Bayer Identifier:

13087

ClinicalTrials.gov Identifier:

NCT00611845

EudraCT Number:

Not Available

Study Completed

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.

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
N/A
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N/A
Phase
N/A
Could I receive a placebo?
No
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Community Memorial Hospital

Ventura, United States, 93003

Status
Completed
 
Locations

Providence St.Vincent Medical Center

Portland, United States, 97225

Status
Completed
 
Locations

Indiana/Ohio Heart

Fort Wayne, United States, 46804

Status
Completed
 
Locations

Legacy Emanuel Hospital & Health Center

Portland, United States, 97210

Status
Terminated
 
Locations

Saint Mary's Medical Center

Knoxville, United States, 37917

Status
Completed
 
Locations

Charles George VA Medical Center

Asheville, United States, 28805

Status
Completed
 
Locations

Central Coast Cardiothoracic Surgical Associates

Pismo Beach, United States, 93449

Status
Completed
 
Locations

Decatur Cardiovascular Surgery

Decatur, United States, 35601

Status
Completed
 
Locations

Aspirus Wausau Hospital

Wausau, United States, 54401

Status
Completed
 
Locations

Office of Dr. Michael Savitt, MD

Milwaukee, United States, 53215

Status
Completed
 
Locations

Robert Wood Johnson University Hospital

New Brunswick, United States, 08903

Status
Completed
 
Locations

Providence Medford Medical Center

Medford, United States, 97504

Status
Completed
 
Locations

Saint John's Health Center

Santa Monica, United States, 90404

Status
Completed
 
Locations

Centra Health Cardiovascular Group

Lynchburg, United States, 24501

Status
Completed
 
Locations

Thomas Jefferson University

Philadelphia, United States, 19107

Status
Completed
 
Locations

Glendale Adventist Medical Center

Glendale, United States, 91206

Status
Completed
 
Locations

St. Elizabeth Medical Center - Edgewood

Edgewood, United States, 41017

Status
Completed
 

For details, please refer to trial results

Additional Information