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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Nov 18, 2026 → Apr 6, 2027
See other at-risk trials from CSL Behring

Record History

  1. Primary completion pushed from Nov 18, 2026 to Apr 6, 2027 Trial sites expanded: 18 → 24 locations · Completion pushed from Dec 17, 2026 to May 5, 2027v10 Show 2 more changesShow less
    • Trial sites expanded: 18 → 24 locations
    • Completion pushed from Dec 17, 2026 to May 5, 2027
  2. Study sites: 19 to 18v9
  3. Site details revised at 2 of 19 sitesv8
  4. Site contacts updated at 2 of 19 sitesv7
  5. Site contacts updated at 2 of 19 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 1 to 19v5
  2. Primary completion date: May 31, 2027 to Nov 18, 2026 Completion date: Jun 30, 2027 to Dec 17, 2026 · Secondary endpoints: details revised at 3 of 18 entries · Eligibility criteria expanded, about 1 wordv4 Show 3 more changesShow less
    • Completion date: Jun 30, 2027 to Dec 17, 2026
    • Secondary endpoints: details revised at 3 of 18 entries
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 10, 2025 to Sep 15, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 10, 2025 to Sep 15, 2025
    • Site details revised
  4. Start date: Jul 31, 2025 to Sep 10, 2025 Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
CSL Behring
30 trials monitored
See 2 trials at risk
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.
Trial Details
NCT Number NCT07094087
Lead Sponsor CSL Behring
Conditions Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov