NCT07094087 - Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB) | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

May 31, 2027

Study Completion Date

June 30, 2027

Conditions

Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Interventions

BIOLOGICAL

BE1116

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

BIOLOGICAL

FFP

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

Trial Locations (1)

84000877- Thomas Jefferson University Hospital, Philadelphia