Clinical trial NCT00611845: Aprotinin US Special Access Protocol
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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Postoperative Hemorrhage
Keywords: CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-02-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
state: Alabama
city: Glendale
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Ventura
country: United States
state: California
city: Fort Wayne
country: United States
state: Indiana
city: Edgewood
country: United States
state: Kentucky
city: New Brunswick
country: United States
state: New Jersey
city: Asheville
country: United States
state: North Carolina
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
city: Lynchburg
country: United States
state: Virginia
city: Milwaukee
country: United States
state: Wisconsin
city: Wausau
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: