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A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

Trial Profile

A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Fibrinogen/thrombin (Primary)
  • Indications Surgical blood loss
  • Focus Registrational; Therapeutic Use
  • Sponsors Grifols
  • Most Recent Events

    • 11 Jan 2023 According to a Grifols media release, based on the results of this study, the company expects to facilitate regulatory approval to expand the use of the FS-based biosurgery treatment to children and adolescents. This study fulfills legal and regulatory obligations as well as supports regulatory licenses from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
    • 11 Jan 2023 Primary endpoint has been met. (Percentage of Subjects Achieving Hemostasis Within 4 Minutes After Treatment Start (T4)), according to a Grifols media release.
    • 11 Jan 2023 Results presented in a Grifols media release.
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