Your browser doesn't support javascript.
loading
A Phase 3, Randomized, Active-controlled, Single-blind Clinical Trial to Evaluate the Efficacy of Fibrin Sealant Grifols in Achieving Hemostasis in Pediatric Surgery.
Balanescu, Laura; Gajdobranski, Djordje; Sretenovic, Aleksandar; Kalinova, Krasimira; Vajda, Péter; Hanna, Kim; Querolt, Montse; Camprubí, Sandra; Mondou, Elsa.
Afiliación
  • 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.
  • Sretenovic 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.
J Pediatr Surg ; : 161639, 2024 Jul 23.
Article en En | MEDLINE | ID: mdl-39142955
ABSTRACT

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 (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) infants were eligible.

RESULTS:

At 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.

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.
Palabras clave
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Pediatr Surg Año: 2024 Tipo del documento: Article País de afiliación: Rumanía Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Pediatr Surg Año: 2024 Tipo del documento: Article País de afiliación: Rumanía Pais de publicación: Estados Unidos