NCT07094087 Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
| NCT ID | NCT07094087 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | CSL Behring |
| Condition | Complex Cardiovascular Surgery With Cardiopulmonary Bypass |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-04-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2025-09-15 with a primary completion date of 2027-04-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Adult greater than or equal to (≥) 18 years and has provided written informed consent. * Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms. * Coagulation factor replacement (ie, 4F-PCC or FFP) is ordered in the operating room for the management of bleeding, in accordance with accepted clinical standards. The following criteria must be met: * INR ≥ 1.6 (point-of-care INR testing by Hemochron ≥ 5 to 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility. * Significant microvascular hemorrhage (ie, not due to surgical complications), as defined by a BSS score of ≥ 2. Exclusion Criteria: * Administration of any systemic hemostatic therapy, such as cryoprecipitate, platelets, FFP, PCC (eg, 4-factor / 3-factor PCC \[4F-PCC / 3F-PCC\]), Factor VIII (FVIII) inhibitor bypassing activity (FEIBA), recombinant activated Factor VIIa (rFVIIa), or other coagulation factor products, in the 24 hours before study surgery, except when FFP is added to the CPB circuit.
Contact & Investigator
Study Director
STUDY DIRECTOR
CSL Behring
Frequently Asked Questions
Who can join the NCT07094087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Complex Cardiovascular Surgery With Cardiopulmonary Bypass. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07094087 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT07094087 currently recruiting?
Yes, NCT07094087 is actively recruiting participants. Contact the research team at clinicaltrials@cslbehring.com for enrollment information.
Where is the NCT07094087 trial being conducted?
This trial is being conducted at Los Angeles, United States, Atlanta, United States, Chicago, United States, Kansas City, United States and 11 additional locations.
Who is sponsoring the NCT07094087 clinical trial?
NCT07094087 is sponsored by CSL Behring. The principal investigator is Study Director at CSL Behring. The trial plans to enroll 200 participants.