Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
A Phase 3, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Safety of 4-Factor Prothrombin Complex Concentrate in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Sponsor: CSL Behring
Listed as NCT07094087, this observational or N/A phase trial focuses on Complex Cardiovascular Surgery With Cardiopulmonary Bypass and remains actively recruiting participants. Sponsored by CSL Behring, it has been updated 5 times since 2025, reflecting limited change activity. This study contributes longitudinal data to the cardiovascular research landscape.
Status Flow
Change History
5 versions recorded-
Apr 17, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE3
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Sep 2025 — Feb 2026 [monthly]
Not Yet Recruiting PHASE3
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Aug 2025 — Sep 2025 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
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.
Contact Information
- CSL Behring
For direct contact, visit the study record on ClinicalTrials.gov .