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 this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80 mg/mL fibrinogen; 500 IU/mL thrombin) and Evicel (fibrinogen 55–85 mg/mL; thrombin 800–1200 IU/mL) were studied for efficacy in achieving hemostasis at a targeted bleeding site (TBS) on parenchymous or soft tissue in pediatric surgeries.