Recruiting
Phase 3

BE1116 vs. FFP

Sponsor:

CSL Behring

Code:

NCT07094087

Conditions

Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BE1116

FFP

Study Details

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

Study ID

NCT07094087

Start date

Sep 15, 2025

Status verified date

Aug, 2026

Completion date

May 5, 2027

Anticipated

Primary completion date

Apr 6, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BE1116

active comparator: Fresh frozen plasma

Interventions

BE1116

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

FFP

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

Primary outcome measure

  • Number of Participants With and Without a Successful Correction of Coagulation Factor Deficiency [ Time Frame: At Day 1 after IP infusion (30 minutes after the end of infusion) ]

Central Contacts and Locations

Central contacts

Trial Registration Coordinator

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

Locations

UCLA Health - Ronald Reagan Medical Center

Recruiting

Los Angeles, California, United States, 90095

University of Maryland Medical Center (UMMC)

Recruiting

Baltimore, Maryland, United States, 21201

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

OUHSC (University of Oklahoma Health Sciences Center)

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Oregon Health & Sciences University

Recruiting

Portland, Oregon, United States, 97239

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

London Health Sciences Center - University Campus

Recruiting

London, Ontario, Canada, N6A 5A5

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

Recruiting

Montreal, Quebec, Canada, H1T1C8

More Information

Sponsor

CSL Behring

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CSL Behring on 2026-08-18.