A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery

In brief

Phase 3 randomized trial comparing two fibrin sealant products (FS Grifols and Evicel) for controlling bleeding at targeted sites during pediatric surgeries involving parenchymal or soft tissue. The study evaluates the efficacy of topical hemostatic agents in achieving hemostasis in the pediatric surgical population.

• FS Grifols (80 mg/mL fibrinogen, 500 IU/mL thrombin) was compared to Evicel for hemostasis in pediatric parenchymal/soft tissue bleeding.
• Phase 3 trial evaluated fibrin sealant efficacy at targeted bleeding sites during pediatric surgical procedures.
• Both products tested for achieving hemostasis in challenging pediatric tissue types (parenchymous and soft tissue).

Written by the GCMD Library team from the article.