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

NCT07094087 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: BE1116_3008
• Study Type: interventional
• Target: 200
• Locations: 4 countries
• Sites: 19

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.

Conditions

Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Keywords

Cardiopulmonary bypass; Coagulopathic Bleeding; Coagulation factor deficiency; Prothrombin complex concentrates; Fresh frozen plasma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With and Without a Successful Correction of Coagulation Factor Deficiency

  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.

  At Day 1 after IP infusion (30 minutes after the end of infusion)

Secondary Outcomes (18)

• Number of Participants With Effective or Not Effective Hemostatic Response from 30 Minutes to 24 Hours After the End of IP Infusion

  Up to 24 hours after the end of IP infusion

• Number of Participants With and Without Successful Correction of Coagulation Factor Deficiency

  At Day 1 after IP infusion (30 minutes after the end of infusion)

• Change in INR from Baseline

  From baseline (before IP infusion), to 30 minutes, 6 hours, 24 hours, and 48 hours after the end IP infusion

• Number of Participants With Effective and Not Effective Hemostatic Response From the Start of IP Infusion to 24 Hours After the Start of IP Infusion

  Up to 24 hours after the start of IP infusion

• Change in Z-Scores for ROTEM EXTEM CT and TEG Reaction Time

  From baseline (before IP infusion) to 30 minutes and 24 hours after the end IP infusion

Study Arms (2)

BE1116

EXPERIMENTAL

Biological: BE1116

Fresh frozen plasma

ACTIVE COMPARATOR

Biological: FFP

Interventions

BE1116 BIOLOGICAL

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

Also known as: 4F-PCC

BE1116

FFP BIOLOGICAL

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

Fresh frozen plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (19)

UCLA Health - Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

NOT YET RECRUITING

University of Chicago Medicine

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

University of Maryland Medical Center (UMMC)

Baltimore, Maryland, 21201, United States

RECRUITING

North Shore University Hospital

Manhasset, New York, 11040, United States

NOT YET RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

OUHSC (University of Oklahoma Health Sciences Center)

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oregon Health & Sciences University

Portland, Oregon, 97239, United States

NOT YET RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

NOT YET RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

NOT YET RECRUITING

Kingston Health Science Center

Kingston, Ontario, K7L 2V7, Canada

NOT YET RECRUITING

London Health Sciences Center - University Campus

London, Ontario, N6A 5A5, Canada

RECRUITING

University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI)

Montreal, Quebec, H1T1C8, Canada

NOT YET RECRUITING

Kyushu University Hospital

Fukuoka, Fukuoka, 812-8582, Japan

RECRUITING

National Cerebral and Cardiovascular Center

Suita, Osaka, 564-8565, Japan

NOT YET RECRUITING

Sakakibara Heart Institute

Fuchu-shi, Tokyo, 183-0003, Japan

NOT YET RECRUITING

Hospital Civil de Guadalajara

Guadalajara, Jalisco, 44100, Mexico

NOT YET RECRUITING

Instituto Nacional de Cardiolgia Ignacio Chavez (National Institute of Cardiology)

Mexico City, Mexico City (cdmx), 14080, Mexico

NOT YET RECRUITING

MeSH Terms

Interventions

Factor IX

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Central Study Contacts

Trial Registration Coordinator

CONTACT

+1 610-878-4697; clinicaltrials@cslbehring.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 30, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 17, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
• Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Locations

CA (4); JP (3); ME (2); US (10)