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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is multicenter, randomized, open-label, parallel group, controlled study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BE1116

Group Type EXPERIMENTAL

BE1116

Intervention Type BIOLOGICAL

A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.

Fresh frozen plasma

Group Type ACTIVE_COMPARATOR

FFP

Intervention Type BIOLOGICAL

A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.

Interventions

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BE1116

A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.

Intervention Type BIOLOGICAL

FFP

A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.

Intervention Type BIOLOGICAL

Other Intervention Names

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4F-PCC

Eligibility Criteria

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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 at least 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No