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NCT07094087 · ClinicalTrials.gov registry record · Phase 3
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 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass, sponsored by CSL Behring.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 19
- Study locations
NCT07094087: Recruiting Phase 3 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass, sponsored by CSL Behring.
NCT07094087 is a Phase 3 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 200 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). The trial reports 19 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07094087, a Phase 3 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass, is actively recruiting participants, sponsored by CSL Behring.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 19
- Study locations
Study 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.
Primary Outcome
Successful correction ("yes" vs "no") of coagulation factor deficiency as measured by an international normalized ratio (INR) of less than or equal to (≤) 1.4 at 30 minutes after the end of IP infusion.
Conditions Studied
Interventions
- BIOLOGICAL BE1116
- BIOLOGICAL FFP
Study Locations (19)
Ontario
- Kingston Health Science Center - Kingston
- London Health Sciences Center - University Campus - London
- University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science - Toronto
California
- UCLA Health - Ronald Reagan Medical Center - Los Angeles
Illinois
- University of Chicago Medicine - Chicago
Maryland
- University of Maryland Medical Center (UMMC) - Baltimore
New York
- North Shore University Hospital - Manhasset
Ohio
- University of Cincinnati - Cincinnati
Oklahoma
- OUHSC (University of Oklahoma Health Sciences Center) - Oklahoma City
Oregon
- Oregon Health & Sciences University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2026-12-17 |
| Phase | Phase 3 |
What NCT07094087 shows while recruiting
NCT07094087 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Complex Cardiovascular Surgery With Cardiopulmonary Bypass appearing as the primary indexed condition, and to 2 interventions - of which BE1116 is the first listed.
NCT07094087 lists 19 locations in 17 states (Ontario, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT07094087 about?
NCT07094087 is a clinical study titled "Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)". 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 ef...
What is the current status of trial NCT07094087?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-09-15. Estimated completion is 2026-12-17.
What conditions does trial NCT07094087 study?
This clinical trial studies the following conditions: Complex Cardiovascular Surgery With Cardiopulmonary Bypass.
What interventions are being tested in trial NCT07094087?
The interventions under investigation include: BE1116 (BIOLOGICAL), FFP (BIOLOGICAL).
Who is sponsoring clinical trial NCT07094087?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07094087 being conducted?
This trial has 19 study locations across California, Illinois, Maryland, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07094087's enrollment target sits among peer trials
200 1354th of 2000 higher than 613 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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