Aprotinin US Special Access Protocol

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Postoperative Hemorrhage

Intervention / Treatment
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* Drug: Aprotinin (Trasylol, BAYA0128)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aprotinin (Trasylol, BAYA0128)|Trasylol at either 1,000,000 KIU or 2,000,000 KIU|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion