Aprotinin US Special Access Protocol

Postoperative Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00611845
• Other study ID #: 13087
• Status: No longer available
• Phase: N/A
• First received: January 29, 2008
• Last updated: June 20, 2014

Study information

• Verified date: June 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Postoperative Hemorrhage

Intervention

Drug:
• Aprotinin (Trasylol, BAYA0128)
Trasylol at either 1,000,000 KIU or 2,000,000 KIU

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

External Links

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