Aprotinin US Special Access Protocol

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.