Behring TAP Trial (Traumatic Injuries with Bleeding) - Clinical Trial
Email to Participate
etienne.jeangilles@duke.edu
What is the Purpose of this Study?
Treatment
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.
What is the Condition Being Studied?
Objective
Traumatic Injuries
Who Can Participate in the Study?
Key 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.
Age Group
Adults, Children
What is Involved?
Description
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
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
Principal Investigator
Gastrointestinal Surgeon
Protocol Number
IRB:
PRO00110332
NCT:
NCT05568888
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate