Clinical Trial

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
View on ClinicalTrials.gov →
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-07-28; most recent amendment 2026-05-08.
Status change: Not Yet Recruiting → Recruiting 2026-01-28
Trial Details
NCT Number NCT07094087
Lead Sponsor CSL Behring
Conditions Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Enrollment 200 participants
Start Date 2025-09-15
Primary Completion 2026-11-18 (estimated)
Study Completion 2026-12-17 (estimated)
Updated on ClinicalTrials.gov 2026-05-11