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Aprotinin US Special Access Protocol

Information source: Bayer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Hemorrhage

Intervention: Aprotinin (Trasylol, BAYA0128) (Drug)

Phase: N/A

Status: Available

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

Clinical Details

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

Study design: N/A

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Decatur, Alabama 35601, United States

Glendale, California 91206, United States

Pismo Beach, California 93449, United States

Santa Monica, California 90404, United States

Ventura, California 93003, United States

Fort Wayne, Indiana 46804, United States

Edgewood, Kentucky 41017, United States

New Brunswick, New Jersey 08903, United States

Asheville, North Carolina 28805, United States

Medford, Oregon 97504, United States

Portland, Oregon 97225, United States

Portland, Oregon 97210, United States

Philadelphia, Pennsylvania 19107, United States

Knoxville, Tennessee 37917, United States

Lynchburg, Virginia 24501, United States

Milwaukee, Wisconsin 53215, United States

Wausau, Wisconsin 54401, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: April 2008
Last updated: January 14, 2013

Page last updated: February 07, 2013

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