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

  • STATUS
    Recruiting
  • End date
    Jul 1, 2022
  • participants needed
    40
  • sponsor
    Ethicon, Inc.
Updated on 22 September 2021
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 on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Paediatric subjects aged 28 days ( 1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects aged 1 years to <18 years. ii) The next 4 subjects to be enrolled will be subjects aged 28 days to <1 year
The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. In addition, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written Informed Consent for the subject will be acceptable for the subject to be included in the study
Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon
Ability to firmly press trial treatment at TBS until 4 minutes after randomisation

Exclusion Criteria

Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products
Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing
Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor
Subjects who are known, current alcohol and/or drug abusers
Subjects admitted for trauma surgery
Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of the EVARREST or SURGICEL to blood flow and pressure during healing and absorption of the product
TBS with major arterial bleeding requiring suture or mechanical ligation
Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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