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

Autor: Balanescu L; Spitalul Clinic de Urgenta pentru Copi 'Grigore Alexandrescu', Bucuresti, Romania., Gajdobranski D; Institute for Health Protection of Children and Youth, Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia., Sretenović A; University Children's Hospital, Belgrade, Serbia., Kalinova K; UMHAT, General and Operative Surgery Clinic, Department of Pediatric Surgery, Stara Zagora, Bulgaria., Vajda P; University of Pécs Clinical Centre, Pécs, Hungary., Hanna K; Grifols Therapeutics LLC, Research Triangle Park, NC, USA., Querolt M; Instituto Grifols, S.A., Sant Cugat, Spain., Camprubí S; Instituto Grifols, S.A., Sant Cugat, Spain., Mondou E; Grifols Therapeutics LLC, Research Triangle Park, NC, USA. Electronic address: Elsa.mondou@grifols.com.
Jazyk: angličtina
Zdroj: Journal of pediatric surgery [J Pediatr Surg] 2024 Nov; Vol. 59 (11), pp. 161639. Date of Electronic Publication: 2024 Jul 23.
DOI: 10.1016/j.jpedsurg.2024.07.024
Abstrakt: Background: 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.
Methods: This phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T 4 - primary endpoint), seven (T 7 ) and 10 (T 10 ) 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) infants were eligible.
Results: At T 4 , 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 T 4 were undergoing soft tissue surgery. All patients achieved hemostasis by T 7 . At T 10 , 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.
Conclusions: FS 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 Evidence: I.
Competing Interests: Conflicts of interest LB, DG, AS, KK, and PV report no competing interests. EM, KH, MQ, and SC are employees of Grifols.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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