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 Confirmed or Suspected Acute Major Bleeding Predicted to Receive a Large Volume Blood Product Transfusion

Protocol No
SURG-CSL-BE1116-3006-TAP
Phase
III
Summary

This is a trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.

Description
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival (TAP Study)
Participating Institutions
Froedtert Hospital
Status
OPEN TO ACCRUAL