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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

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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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2024

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At a glance

  • Drugs Prothrombin complex concentrate (Primary)
  • Indications Haemorrhage
  • Focus Therapeutic Use
  • Sponsors CSL

    • Most Recent Events

    • 09 May 2024 Planned End Date changed from 1 Jan 2028 to 1 Sep 2026.
    • 09 May 2024 Planned primary completion date changed from 1 Jan 2028 to 1 Sep 2026.
    • 06 May 2024 Planned End Date changed from 1 Sep 2026 to 1 Jan 2028.

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