Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
Recruiting now · Phase 3
Conditions studied: Complex Cardiovascular Surgery With Cardiopulmonary Bypass
In brief
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.
Key facts
- Study ID
- NCT07094087
- Run by
- CSL Behring
- People needed
- 200
- Starts
- 2025-09-15
- Expected to finish
- 2026-12-17
- Last updated by the study team
- 2026-05-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Administration of any systemic hemostatic therapy, such as cryoprecipitate, platelets, FFP, PCC (eg, 4-factor / 3-factor PCC [4F-PCC / 3F-PCC]), Factor VIII (FVIII) inhibitor bypassing activity (FEIBA), recombinant activated Factor VIIa (rFVIIa), or other coagulation factor products, in the 24 hours before study surgery, except when FFP is added to the CPB circuit.
Where it is running
- OUHSC (University of Oklahoma Health Sciences Center) — Oklahoma City, Oklahoma, United States (enrolling)
- London Health Sciences Center - University Campus — London, Ontario, Canada (enrolling)
- Oregon Health & Sciences University — Portland, Oregon, United States (enrolling)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
- Kyushu University Hospital — Fukuoka, Fukuoka, Japan (enrolling)
- University of Maryland Medical Center (UMMC) — Baltimore, Maryland, United States (enrolling)
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
- UCLA Health - Ronald Reagan Medical Center — Los Angeles, California, United States (enrolling)
- National Cerebral and Cardiovascular Center — Suita, Osaka, Japan
- Sakakibara Heart Institute — Fuchu-shi, Tokyo, Japan
- Hospital Civil de Guadalajara — Guadalajara, Jalisco, Mexico
- University of Chicago Medicine — Chicago, Illinois, United States
- North Shore University Hospital — Manhasset, New York, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
- Kingston Health Science Center — Kingston, Ontario, Canada
- University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science — Toronto, Ontario, Canada
- Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI) — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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