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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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ClinicalTrials.gov Identifier: NCT05568888
Recruitment Status : Recruiting
First Posted : October 6, 2022
Last Update Posted : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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.

Condition or disease Intervention/treatment Phase
Traumatic Injury Drug: BE1116 Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 28, 2023
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: BE1116
Administration by IV infusion
 Drug: BE1116
4-Factor Prothrombin Complex administered by intravenous (IV) infusion
Other Names:
  • 4-Factor Prothrombin Complex
  • Kcentra®
  • Beriplex®
Placebo Comparator: Placebo
Administration by IV infusion
 Drug: Placebo
Administered by IV infusion


Outcome Measures
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Primary Outcome Measures :
  1. Difference in proportion of subjects in all-cause mortality in the BE1116 arm compared with the placebo arm [ Time Frame: Up to 6 hours after randomization ]

Secondary Outcome Measures :
  1. Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm [ Time Frame: Up to 24 hours after randomization ]
    In-hospital mortality will only be recorded and assessed for the primary hospitalization.

  2. Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm [ Time Frame: Up to 30 days after randomization ]
    In-hospital mortality will only be recorded and assessed for the primary hospitalization.

  3. Difference in proportion of subjects who undergo surgical or interventional radiological procedures to stop bleeding related to the primary injury in the BE1116 arm compared with the placebo arm [ Time Frame: Up to 24 hours after randomization ]
  4. Number and proportion of subjects with serious adverse events (SAEs) considered related to BE1116 or placebo [ Time Frame: Up to 30 days after randomization ]
  5. Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo [ Time Frame: Up to 30 days after randomization ]
    Thromboembolic events (TEEs), symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke [including thromboembolic stroke], myocardial infarction). Superficial thromboses will not be included as adverse events of special interest.

  6. Number and proportion of subjects with Acute respiratory distress syndrome (ARDS) to BE1116 or placebo [ Time Frame: Up to 30 days after randomization ]
  7. Number and proportion of subjects with Multiple organ failure to BE1116 or placebo [ Time Frame: Up to 30 days after randomization ]
  8. Number and proportion of subjects with Acute kidney injury (AKI) requiring renal replacement therapy (dialysis, hemofiltration, or hemodiafiltration) to BE1116 or placebo [ Time Frame: Up to 30 days after randomization ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05568888


Contacts
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Contact: Trial Registration Coordinator +1 610-878-4000 clinicaltrials@cslbehring.com

Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT05568888    
Other Study ID Numbers: BE1116_3006
2021-005060-21 ( EudraCT Number )
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Access Criteria:

Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Thrombin
Hemostatics
Coagulants