Behring TAP Trial (Traumatic Injuries with Bleeding) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Traumatic Injuries

Who Can Participate in the Study?

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

Age Group
Adults, Children

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

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 III
Enrollment Status
Open for Enrollment