RECRUITING Phase 3 ClinicalTrials.gov

Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)

Sponsor: CSL Behring • ClinicalTrials.gov ID: NCT07094087

Registry updated: 2026-10-15

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Description

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.

Interventions

BE1116 (Biological)
A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.
FFP (Biological)
A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.

Eligibility criteria

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 (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. Exclusion Criteria: * 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.

Conditions

Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Locations

UCLA Health - Ronald Reagan Medical Center — Los Angeles, California, United States
Emory University Hospital — Atlanta, Georgia, United States
University of Chicago Medicine — Chicago, Illinois, United States
University of Kansas Medical Center (KUMC) — Kansas City, Kansas, United States
University of Maryland Medical Center (UMMC) — Baltimore, Maryland, United States
Johns Hopkins Medicine — Baltimore, Maryland, United States
Cooper University Healthcare — Camden, New Jersey, United States
North Shore University Hospital — Manhasset, New York, United States
University of Cincinnati — Cincinnati, Ohio, United States
OUHSC (University of Oklahoma Health Sciences Center) — Oklahoma City, Oklahoma, United States
Oregon Health & Sciences University — Portland, Oregon, United States
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center (VUMC) — Nashville, Tennessee, United States
UT Southwestern Medical Center — Dallas, Texas, United States
University of Utah — Salt Lake City, Utah, United States
University of Virginia Health System — Charlottesville, Virginia, United States
Kingston Health Science Center — Kingston, Ontario, Canada
London Health Sciences Center - University Campus — London, 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
Kyushu University Hospital — Fukuoka, Fukuoka, Japan
National Cerebral and Cardiovascular Center — Suita, Osaka, Japan
Sakakibara Heart Institute — Fuchu-shi, Tokyo, Japan
Hospital Civil de Guadalajara — Guadalajara, Jalisco, Mexico

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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