The trial is taking place at:
E

Erie County Medical Center | Department of Medical Oncology

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

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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

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

Trial contacts and locations

113

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Central trial contact

Trial Registration Coordinator

Data sourced from clinicaltrials.gov

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