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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Traumatic Injury

In brief

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.

Key facts

Study ID

NCT05568888

Run by

CSL Behring

People needed

1366

Starts

2023-03-28

Expected to finish

2024-10-29

Last updated by the study team

2025-12-10

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (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

You may not qualify if…

• 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.

Where it is running

• 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
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Riverside University Health System Medical Center — Moreno Valley, California, United States
• UC Irvine — Orange, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UC San Diego Medical Center — San Diego, California, United States
• San Francisco General Hospital and Trauma Center — San Francisco, California, United States
• University of Colorado Aurora — Aurora, Colorado, United States
• UC Health Memorial Hospital Central — Colorado Springs, Colorado, United States
• Denver Health and Hospital Authority — Denver, Colorado, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• MedStar Washington Medical Center — Washington D.C., District of Columbia, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• UF Health Jacksonville — Jacksonville, Florida, United States
• University of Miami/Ryder Trauma Center — Miami, Florida, United States
• UAB Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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