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Fibrin Sealant Grifols

Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

Ensayo de Grifols SA en sangrado quirurgico del tejido parequimatoso.

Fase

Fase 3

Estado

Completado

Participantes

325

previstos

Centros

33

Fin del objetivo primario

dic 2015

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado. Comenzó en mar 2013.

Qué mide

Proporcion de sujetos que logran hemostasia cuatro minutos después del inicio del tratamiento (From start of treatment until 4 minutes after treatment start) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the liver). The purpose of this study is to demonstrate that Fibrin Sealant Grifols is not inferior to commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for study teams to become familiar with the application of Fibrin Sealant Grifols and to assess safety and a Primary Part (II) to assess the safety and efficacy of Fibrin Sealant Grifols. In both parts of the study, patients will be randomized in a 1:1 ratio to either Fibrin Sealant Grifols or Surgicel.

Más ensayos de GRFS

Todos los de GRFS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01754480), actualizada en dic 2016.