Traumatic Injury

Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
NCT05568888 | Phase 3 | Interventional

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.

Trial Information
5 Sites
8000 Participants
Recruiting
15 Years

If interested, contact clinicaltrials@cslbehring.com for more information

SUBMIT
UAB Hospital
Birmingham,Alabama,United States,35233
Chandler Regional Medical Center
Chandler,Arizona,United States,85224
St. Joseph's Hospital and Medical Center
Phoenix,Arizona,United States,85013
Barnes Jewish Hospital
Saint Louis,Missouri,United States,63110
Harborview Medical Center
Seattle,Washington,United States,98104

Study Eligibility 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
  • 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov