Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
Public ClinicalTrials.gov record NCT07094087. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07094087
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2025
- Primary completion
- Apr 5, 2027
- Completion
- May 4, 2027
- Last update posted
- Aug 17, 2026
2025 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 15
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Health - Ronald Reagan Medical Center | Los Angeles | California | 90095 | Recruiting |
| Emory University Hospital | Atlanta | Georgia | 30322 | Not yet recruiting |
| University of Chicago Medicine | Chicago | Illinois | 60637 | Not yet recruiting |
| University of Kansas Medical Center (KUMC) | Kansas City | Kansas | 66160 | Not yet recruiting |
| University of Maryland Medical Center (UMMC) | Baltimore | Maryland | 21201 | Recruiting |
| Johns Hopkins Medicine | Baltimore | Maryland | 21287 | Not yet recruiting |
| Cooper University Healthcare | Camden | New Jersey | 08103 | Not yet recruiting |
| North Shore University Hospital | Manhasset | New York | 11040 | Not yet recruiting |
| University of Cincinnati | Cincinnati | Ohio | 45267 | Recruiting |
| OUHSC (University of Oklahoma Health Sciences Center) | Oklahoma City | Oklahoma | 73104 | Recruiting |
| Oregon Health & Sciences University | Portland | Oregon | 97239 | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Vanderbilt University Medical Center (VUMC) | Nashville | Tennessee | 37232 | Not yet recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| University of Utah | Salt Lake City | Utah | 84108 | Not yet recruiting |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07094087, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 17, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07094087 live on ClinicalTrials.gov.