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Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

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

NCT05568888•CSL Behring

View on ClinicalTrials.gov

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.

Eligibility

Age

15 - No limit years

Sex

ALL

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.

Locations (113)

UAB Hospital

Birmingham, Alabama, United States

University of South Alabama

Mobile, Alabama, United States

Chandler Regional Medical Center

Chandler, Arizona, United States

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Valleywise Medical Center

Phoenix, Arizona, United States

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, United States

University Medical Center Tucson

Tucson, Arizona, United States

UAMS Medical Center

Little Rock, Arkansas, United States

LAC+USC Medical Center

Los Angeles, California, United States

Key Dates

Start Date

March 28, 2023

Primary Completion Date

October 29, 2024

Completion Date

October 29, 2024

Last Updated

December 10, 2025

Enrollment

1,366

ACTUAL participants

Conditions

Traumatic Injury

Interventions

BE1116

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pediatric and Caregiver Traumatic Stress Intervention (PACTS)

Hyperbaric Oxygenation (HBO) in Traumatic Spinal Cord Injury. (EOS) - Pilot Study

DSUVIA Early Evaluation of Pain Trial

Non-severe Traumatic Injuries Evaluation Using smartPhone Camera for Extra-hospital Regulation

Prevention of Injury in Military Settings Through the Use of Body Awareness.

Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma