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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Ethicon, Inc.
Updated on 4 August 2021
Investigator
Patricia Schleckser, MD
Primary Contact
Clinical Investigation Site #31 (0.0 mi away) Contact
+9 other location
fibrinogen
fibrin

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.

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.

Details
Condition Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
Treatment EVARREST™ Sealant Matrix, SURGICEL®
Clinical Study IdentifierNCT02227992
SponsorEthicon, Inc.
Last Modified on4 August 2021

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