- * 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 (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms.
- * Coagulation factor replacement (ie, 4F-PCC or FFP) is ordered in the operating room for the management of bleeding, in accordance with accepted clinical standards. The following criteria must be met:
- * INR ≥ 1.6 (point-of-care INR testing by Hemochron ≥ 5 to 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility.
- * Significant microvascular hemorrhage (ie, not due to surgical complications), as defined by a BSS score of ≥ 2.
Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
NCT07094087 | PHASE 3 | INTERVENTIONAL
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.
Trial Information
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UCLA Health Ronald Reagan Medical Center
Los Angeles,California,United States,90095
University of Chicago Medicine
Chicago,Illinois,United States,60637
University of Maryland Medical Center (UMMC)
Baltimore,Maryland,United States,21201
North Shore University Hospital
Manhasset,New York,United States,11040
University of Cincinnati
Cincinnati,Ohio,United States,45267
OUHSC (University of Oklahoma Health Sciences Center)
Oklahoma City,Oklahoma,United States,73104
Oregon Health & Sciences University
Portland,Oregon,United States,97239
Thomas Jefferson University Hospital
Philadelphia,Pennsylvania,United States,19107
UT Southwestern Medical Center
Dallas,Texas,United States,75390
University of Virginia Health System
Charlottesville,Virginia,United States,22908
Kingston Health Science Center
Kingston,Ontario,Canada,K7L2V7
London Health Sciences Center University Campus
London,Ontario,Canada,N6A5A5
University of Toronto St. Michael's Hospital (SMH) Keenan Research Centre for Biomedical Science
Toronto,Ontario,Canada,M5B1W8
Universite de MontrealInstitut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI)
Montreal,Quebec,Canada,H1T1C8
Kyushu University Hospital
Fukuoka,Fukuoka,Japan,812-8582
National Cerebral and Cardiovascular Center
Suita,Osaka,Japan,564-8565
Sakakibara Heart Institute
Fuchu-shi,Tokyo,Japan,183-0003
Hospital Civil de Guadalajara
Guadalajara,Jalisco,Mexico,44100
Instituto Nacional de Cardiolgia Ignacio Chavez (National Institute of Cardiology)
Mexico City,Mexico City (cdmx),Mexico,14080
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov