NCT02227992

The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study

A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Paediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 28 Days – 17 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue \& parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.

Detailed description

This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients. At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation. Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to \<18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to \<1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment. Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery.

Conditions

• Hemorrhage
• Soft Tissue Bleeding
• Hepatic Parenchyma Bleeding

Interventions

Type	Name	Description
BIOLOGICAL	EVARREST™ Sealant Matrix	EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
DEVICE	SURGICEL®	SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Timeline

• Start date: 2014-07-01
• Primary completion: 2021-10-27
• Completion: 2021-11-12
• First posted: 2014-08-28
• Last updated: 2023-09-08
• Results posted: 2023-09-08

Locations

10 sites across 2 countries: Belgium, United Kingdom