The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

Hemorrhage Clinical Trial

Official title: A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients

Status Completed

Clinical Trial Summary

To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.

Clinical Trial Description

This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients.

At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.

Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to <18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to <1 years of age.

Subjects will be followed post-operatively through hospital discharge and at 30 days (±14 days) post-surgery. ;

Related Conditions & MeSH terms

• Hemorrhage
• Soft Tissue Bleeding

• NCT number: NCT02227706
• Study type: Interventional
• Source: Ethicon, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2014
• Completion date: May 17, 2019