A phase 3, randomized, active-controlled, single-blind clinical trial to evaluate the efficacy of Fibrin Sealant Grifols in achieving hemostasis in pediatric surgery
Laura Balanescu, Djordje Gajdobranski, Aleksandar Sretenović, Krasimira Kalinova, Péter Vajda, the Fibrin Sealant Pediatric Surgery Study Group, Isodoro Wiener, Zoltan Jenovari, Maja Mikickovic, Krasimir Kamenov, Simeon Simeonov, Borislav Ninov, Khalid Sharif, Andjelka Slavkovic, Sabine Irtan, Michael K. James, Jordi Bozzo, Kim Hanna, Montse Querolt, Sandra Camprubí, Elsa Mondou
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引用次数: 0
Abstract
In 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. This phase 3, single-blind, active comparator, non-inferiority trial compared the number of patients achieving hemostasis at a TBS at four (T - primary endpoint), seven (T) and 10 (T) 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. At T, 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 were undergoing soft tissue surgery. All patients achieved hemostasis by T. At T, all patients achieved hemostasis except one (FS Grifols (no observation recorded). There were no incidents of persistent bleeding. 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. I
期刊介绍:
The journal presents original contributions as well as a complete international abstracts section and other special departments to provide the most current source of information and references in pediatric surgery. The journal is based on the need to improve the surgical care of infants and children, not only through advances in physiology, pathology and surgical techniques, but also by attention to the unique emotional and physical needs of the young patient.