Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Thrombin

Criteria

Inclusion Criteria:

• Estimated age ≥ 15 years and weight > 50 kg (110 lbs)

• Traumatic injury with confirmed or suspected acute major bleeding and/or Revised Assessment of Bleeding and Transfusion (RABT) score ≥ 2

• Activation of massive transfusion protocol

Exclusion Criteria:

• Cardiopulmonary resuscitation for ≥ 5 consecutive minutes at any time before enrollment

• Isolated penetrating or blunt cranial injury, or exposed brain matter

• Isolated burns estimated to be > 20% total body surface area or suspected inhalational injury

• Known anticoagulation treatment or a history of a TEE, within the past 3 months.