Purpose of this Study
We are doing this study to find out if an experimental drug called BE1116 (the study drug) has the potential to saves lives by reducing bleeding in people who have had a traumatic injury.
Who Can Participate?
Eligibility
Children and adults ages 15+ who suffer a traumatic injury that involves blood loss.
For more information about who can join this study, please contact the study team at etienne.jeangilles@duke.edu.
For more information about who can join this study, please contact the study team at etienne.jeangilles@duke.edu.
Age Range
15-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you agree to be in this study, you will:
- Get a random assignment (like a coin flip) to either get study drug or placebo (harmless, inactive saline) through a vein in your arm
- Have your health information collected from your medical records
- Get a random assignment (like a coin flip) to either get study drug or placebo (harmless, inactive saline) through a vein in your arm
- Have your health information collected from your medical records
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Evenings
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large
Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex
Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleeding
Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex
Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleeding
Principal Investigator
Suresh
Agarwal
Protocol Number
PRO00110332
NCT ID
NCT05568888
Phase
III
Enrollment Status
OPEN TO ACCRUAL