Clinical Trials

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

• Short Title CSL Behring BE1116_3006
• Category Trauma/Surgery and Vascular
• Status Recruiting

Participating Locations

Erlanger

Principal Investigator

Robert Maxwell, MD

Contact

• Name Erlanger Institute for Clinical Research
• Phone 423-778-3900
• Email [email protected]

Description

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.

InclusionNotes

Inclusion Criteria:

• (a) Estimated age ≥ 15 years AND (b) Estimated or actual weight ≥ 50 kg (110 lbs). Older minimum age is required in some locations.
• 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:

• Healthcare professional cardiopulmonary resuscitation including chest compressions for ≥ 5 consecutive minutes at any time before randomization.
• 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.