Trial Condition(s):
Aprotinin US Special Access Protocol
13087
Not Available
Not Available
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.
- 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
- 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 | |
---|---|
Locations Community Memorial Hospital Ventura, United States, 93003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Providence St.Vincent Medical Center Portland, United States, 97225 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Indiana/Ohio Heart Fort Wayne, United States, 46804 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Legacy Emanuel Hospital & Health Center Portland, United States, 97210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saint Mary's Medical Center Knoxville, United States, 37917 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charles George VA Medical Center Asheville, United States, 28805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Coast Cardiothoracic Surgical Associates Pismo Beach, United States, 93449 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Decatur Cardiovascular Surgery Decatur, United States, 35601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aspirus Wausau Hospital Wausau, United States, 54401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Office of Dr. Michael Savitt, MD Milwaukee, United States, 53215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Robert Wood Johnson University Hospital New Brunswick, United States, 08903 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Providence Medford Medical Center Medford, United States, 97504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saint John's Health Center Santa Monica, United States, 90404 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centra Health Cardiovascular Group Lynchburg, United States, 24501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thomas Jefferson University Philadelphia, United States, 19107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Glendale Adventist Medical Center Glendale, United States, 91206 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Elizabeth Medical Center - Edgewood Edgewood, United States, 41017 | Contact Us: E-mail: [email protected] Phone: Not Available |