check_circleStudy Completed

Postoperative Hemorrhage

Bayer Identifier:

13087

ClinicalTrials.gov Identifier:

NCT00611845

EudraCT Number:

Not Available

EU CT Number:

Not Available
Aprotinin US Special Access Protocol

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - 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.

Trial summary

Enrollment Goal
N/A
Trial Dates
null - Today
Phase
N/A
Could I Receive a placebo
No
Products
Trasylol (Aprotinin, BAYA0128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Community Memorial HospitalVentura, 93003, United States
Completed
Providence St.Vincent Medical CenterPortland, 97225, United States
Completed
Indiana/Ohio HeartFort Wayne, 46804, United States
Terminated
Legacy Emanuel Hospital & Health CenterPortland, 97210, United States
Completed
Saint Mary's Medical CenterKnoxville, 37917, United States
Completed
Charles George VA Medical CenterAsheville, 28805, United States
Completed
Central Coast Cardiothoracic Surgical AssociatesPismo Beach, 93449, United States
Completed
Decatur Cardiovascular SurgeryDecatur, 35601, United States
Completed
Aspirus Wausau HospitalWausau, 54401, United States
Completed
Office of Dr. Michael Savitt, MDMilwaukee, 53215, United States
Completed
Robert Wood Johnson University HospitalNew Brunswick, 08903, United States
Completed
Providence Medford Medical CenterMedford, 97504, United States
Completed
Saint John's Health CenterSanta Monica, 90404, United States
Completed
Centra Health Cardiovascular GroupLynchburg, 24501, United States
Completed
Thomas Jefferson UniversityPhiladelphia, 19107, United States
Completed
Glendale Adventist Medical CenterGlendale, 91206, United States
Completed
St. Elizabeth Medical Center - EdgewoodEdgewood, 41017, United States

Trial design

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
Trial Type
Expanded Access
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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