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
Study identification
- NCT ID
- NCT07094087
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- CSL Behring
- Industry
- Enrollment
- 200 participants
Conditions and interventions
Interventions
- BE1116 Biological
- FFP Biological
Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
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
- Nov 17, 2026
- Completion
- Dec 16, 2026
- Last update posted
- Apr 15, 2026
2025 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Health - Ronald Reagan Medical Center | Los Angeles | California | 90095 | Not yet recruiting |
| University of Chicago Medicine | Chicago | Illinois | 60637 | Not yet recruiting |
| University of Maryland Medical Center (UMMC) | Baltimore | Maryland | 21201 | 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 | Not yet recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | 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 9 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 Apr 15, 2026 · Synced Apr 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07094087 live on ClinicalTrials.gov.