Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
Recruiting · Phase 3 · NCT07094087
Conditions: Complex Cardiovascular Surgery With Cardiopulmonary Bypass
At a glance
- Research payments reported, 2025
- $60,469
- U.S. investigators named
- 1
- Sites paid
- 2
- Planned or actual enrollment
- 200
About the trial
- Sponsor
- CSL Behring
- Tested
- BE1116 (biological), FFP (biological)
- Dates
- Started 2025-09-15; completion 2027-05-05
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-10-15. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Csl Behring reported $60,469 in research payments for this study in 2025 (4 payments).
Products named: Kcentra
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Thomas Jefferson University $36,629
- Thomas Jefferson University Hospital, PA $23,840
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.