Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

CSL Behring

Status and phase: Enrolling; Phase 3

Conditions: Traumatic Injury

Treatments: Drug: BE1116; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05568888

2021-005060-21 (EudraCT Number)

BE1116_3006

Details and patient eligibility

About

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.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (a) Estimated age ≥ 15 years. Older minimum age is required in some locations. FOR United Kingdom: Estimated or actual age ≥ 16 years FOR Australia: Estimated or actual age ≥ 18 years AND (b) Estimated or actual 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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,000 participants in 2 patient groups, including a placebo group

BE1116

Experimental group

Description:

Administration by IV infusion

Treatment:

Drug: BE1116

Placebo

Placebo Comparator group

Description:

Administration by IV infusion

Treatment:

Drug: Placebo