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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

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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: 01 Nov 2024

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At a glance

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

Most Recent Events

  • 01 Nov 2024 Results discussing efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries , published in the Journal of Pediatric Surgery
  • 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.

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