A Phase 3, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Safety of 4-Factor Prothrombin Complex Concentrate in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass
CSL Behring
Summary
This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing complex cardiovascular surgery with CPB.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult greater than or equal to (≥) 18 years and has provided written informed consent. * Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (exce…
Interventions
- BiologicalBE1116
A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.
- BiologicalFFP
A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.
Locations (19)
- UCLA Health - Ronald Reagan Medical CenterLos Angeles, California
- University of Chicago MedicineChicago, Illinois
- University of Maryland Medical Center (UMMC)Baltimore, Maryland
- North Shore University HospitalManhasset, New York
- University of CincinnatiCincinnati, Ohio
- OUHSC (University of Oklahoma Health Sciences Center)Oklahoma City, Oklahoma