A phase 3, randomized, active-controlled, single-blind clinical trial to evaluate the efficacy of Fibrin Sealant Grifols in achieving hemostasis in pediatric surgery

Abstract

BACKGROUNDIn this study, two fibrin sealant products, Fibrin Sealant Grifols (FS Grifols 80mg/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. M ETHODSThis phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T4 - primary endpoint), seven (T7) and 10 (T10) minutes after application, Safety and tolerability were assessed by recording adverse events during and after procedures. Eligible patients were <18 years old undergoing elective, open, non-cardiac thoracic, abdominal or pelvic surgeries. Preterm (<37 weeks gestation) and newborn (0-27 days) were eligible. RESULTSAt T4, 98.7% of FS Grifols group (n= 91) and 95.4% of the Evicel group (n = 87) achieved hemostasis . All patients with residual bleeding at T4 were undergoing soft tissue surgery. All patients achieved hemostasis by T7. At T10, all patients achieved hemostasis except one (FS Grifols (no observation recorded). There were no incidents of persistent bleeding.For FS Grifols, 26.5% of patients had treatment-emergent adverse events (TEAEs) and 18.4% for Evicel. One TEAE (moderate procedural pain - FS Grifols group) was considered possibly related to study treatment. Three patients died for reasons unrelated to the study medications. CONCLUSIONSFS Grifols was safe and effective at achieving hemostasis in pediatric patients having parenchymous or soft tissue surgeries. The efficacy of FS Grifols was non-inferior to Evicel. Level of evidenceI