Aprotinin US Special Access Protocol

This is an expanded access trial for Postoperative Hemorrhage focused on measuring CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion Read More

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.