Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aprotinin Use and Renal Outcome in Hypothermic Bypass and Circulatory Arrest for Surgical Repair of Thoracic Aorta.
NCT00405093
Cardiac Surgery: In Vivo Titration of Protamine
NCT00684450
Clinical Trial Comparing Heparin and Protamine Fixed and Titrated Doses in Cardiac Surgery With Cardiopulmonary Bypass
NCT01267487
Fibrinogen and Bleeding After Cardiac Surgery
NCT00968045
Apixaban Pharmacokinetics in Bariatric Patients (APB)
NCT02406885
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aprotinin (Trasylol, BAYA0128)
Trasylol at either 1,000,000 KIU or 2,000,000 KIU
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 allergy to aprotinin.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bayer Healthcare AG
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Decatur, Alabama, United States
Glendale, California, United States
Pismo Beach, California, United States
Santa Monica, California, United States
Ventura, California, United States
Fort Wayne, Indiana, United States
Edgewood, Kentucky, United States
New Brunswick, New Jersey, United States
Asheville, North Carolina, United States
Medford, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Lynchburg, Virginia, United States
Milwaukee, Wisconsin, United States
Wausau, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13087
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.