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Prospective, Multi-center, Randomized, Active-control, Non-inferiority Study Comparing Fibrinogen Concentrate With Cryoprecipitate for the Treatment of Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients

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Trial Profile

Prospective, Multi-center, Randomized, Active-control, Non-inferiority Study Comparing Fibrinogen Concentrate With Cryoprecipitate for the Treatment of Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Aug 2024

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At a glance

  • Drugs Fibrinogen (Primary)
  • Indications Afibrinogenaemia
  • Focus Therapeutic Use
  • Acronyms FIBRES

    • Most Recent Events

    • 01 Aug 2024 According to an Octapharma media release, company announced the expanded approval of fibryga Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the U.S. Food and Drug Administration (FDA) based on the results of FIBRES trial.
    • 27 Jun 2022 Results of post hoc analysis comparing fibrinogen concentrate (4 g) to cryoprecipitate, published in the British Journal of Anaesthesia
    • 14 Sep 2021 Results (n=415) of post-hoc analysis of FIBRES study comparing fibrinogen concentrate with cryoprecipitate in bleeding cardiac surgical patients published in the Canadian Journal of Anesthesia

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