Actively Recruiting
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
Led by CSL Behring · Updated on 2026-05-11
200
Participants Needed
18
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who have provided written informed consent
- Undergoing elective complex cardiovascular surgery requiring cardiopulmonary bypass, including thoracic aorta procedures (with or without additional cardiac interventions), aortic valve replacement with coronary artery bypass graft, complex valve surgeries, mitral valve repair with bypass graft, mitral valve replacement with bypass graft, or reoperative coronary artery bypass graft
- Coagulation factor replacement (4F-PCC or FFP) ordered during surgery to manage bleeding
- INR of 1.6 or higher measured 5 to 10 minutes after protamine infusion for heparin reversal
- Significant microvascular bleeding with a bleeding severity score of 2 or higher, not due to surgical complications
You will not qualify if you...
- Received any systemic hemostatic therapy such as cryoprecipitate, platelets, FFP, PCC (4F-PCC or 3F-PCC), FEIBA, recombinant activated Factor VIIa, or other coagulation factor products within 24 hours before surgery, except when FFP is added to the cardiopulmonary bypass circuit
- Undergoing heart transplantation
- Undergoing insertion or removal of ventricular assist devices (except intra-aortic balloon pumps)
- Undergoing acute repair of thoracoabdominal aneurysms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
UCLA Health - Ronald Reagan Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Not Yet Recruiting
3
University of Maryland Medical Center (UMMC)
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
North Shore University Hospital
Manhasset, New York, United States, 11040
Not Yet Recruiting
5
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
6
OUHSC (University of Oklahoma Health Sciences Center)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
7
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
8
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
9
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Not Yet Recruiting
10
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Not Yet Recruiting
11
Kingston Health Science Center
Kingston, Ontario, Canada, K7L 2V7
Not Yet Recruiting
12
London Health Sciences Center - University Campus
London, Ontario, Canada, N6A 5A5
Actively Recruiting
13
University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
14
Universite de Montreal-Institut de Cardiologie de Montreal (ICM) Montreal Heart Institute (MHI)
Montreal, Quebec, Canada, H1T1C8
Not Yet Recruiting
15
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
16
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 564-8565
Not Yet Recruiting
17
Sakakibara Heart Institute
Fuchu-shi, Tokyo, Japan, 183-0003
Not Yet Recruiting
18
Hospital Civil de Guadalajara
Guadalajara, Jalisco, Mexico, 44100
Not Yet Recruiting
Research Team
T
Trial Registration Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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