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Study identifier: NCT07094087 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Complex Cardiovascular Surgery With Cardiopulmonary Bypass  ·  Sponsor: CSL Behring

PhasePhase 3
Planned participants200
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Trial Registration Coordinator  ·  +1 610-878-4697  ·  clinicaltrials@cslbehring.com

Always discuss trial participation with your own doctor first.

Locations (18)

UCLA Health - Ronald Reagan Medical CenterLos Angeles, California, United StatesRecruiting
University of Chicago MedicineChicago, Illinois, United StatesNot Yet Recruiting
University of Maryland Medical Center (UMMC)Baltimore, Maryland, United StatesRecruiting
North Shore University HospitalManhasset, New York, United StatesNot Yet Recruiting
University of CincinnatiCincinnati, Ohio, United StatesRecruiting
OUHSC (University of Oklahoma Health Sciences Center)Oklahoma City, Oklahoma, United StatesRecruiting
Oregon Health & Sciences UniversityPortland, Oregon, United StatesRecruiting
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania, United StatesRecruiting
UT Southwestern Medical CenterDallas, Texas, United StatesNot Yet Recruiting
University of Virginia Health SystemCharlottesville, Virginia, United StatesNot Yet Recruiting
Kingston Health Science CenterKingston, Ontario, CanadaNot Yet Recruiting
London Health Sciences Center - University CampusLondon, Ontario, CanadaRecruiting

+ 6 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07094087