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

CSL Behring111 sites in 1 country1,366 target enrollmentMarch 28, 2023

ConditionsTraumatic Injury

InterventionsBE1116 Placebo

DrugsBE1116 Placebo

Overview

Phase: Phase 3
Intervention: BE1116
Conditions: Traumatic Injury
Sponsor: CSL Behring
Enrollment: 1366
Locations: 111
Primary Endpoint: Proportion of Participants With All-cause 6-hour Mortality
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 28, 2023

End Date

October 29, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSL Behring

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

BE1116

Administration by IV infusion

Intervention: BE1116

Placebo

Administration by IV infusion

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of Participants With All-cause 6-hour Mortality

Time Frame: Up to 6 hours after randomization

Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.

Secondary Outcomes

Proportion of Participants With All-cause 24-hour In-hospital Mortality(Up to 24 hours after randomization)
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization(Up to 30 days after randomization)
Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury(Up to 24 hours after randomization)
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)(Up to 30 days after randomization)
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)(Up to 30 days after randomization)
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)(Up to 30 days after randomization)
Number of Participants With Multiple Organ Failure(Up to 30 days after randomization)
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy(Up to 30 days after randomization)