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

NCT02227992 | Completed Phase 3 Results

• 2 other identifiers: 400-12-0042013-003557-24
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Hemorrhage; Soft Tissue Bleeding; Hepatic Parenchyma Bleeding

Keywords

Fibrin Sealant; Hemostatics; Coagulants

Outcome Measures

Primary Outcomes (2)

• Absolute Time to Haemostasis (TTH)

  Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed.

  Up to 1 day (Intraoperative)

• Absolute Time to Haemostasis (TTH) by Age Group

  Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed.

  Up to 1 day (Intraoperative)

Secondary Outcomes (12)

• Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure

  4 minutes post randomization (up to 1 day; intraoperative)

• Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure

  10 minutes post randomization (up to 1 day; intraoperative)

• Percentage of Participants With No Re-bleeding at the Target Bleeding Site

  Up to 44 days post-surgery on Day 0

• Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS

  Up to 44 days post-surgery on Day 0

• Number of Participants With AEs That Were Potentially Related To Thrombotic Events

  Up to 44 days post-surgery on Day 0

Study Arms (2)

EVARREST™ Sealant Matrix

EXPERIMENTAL

EVARREST™ Sealant Matrix/Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).

Biological: EVARREST™ Sealant Matrix

SURGICEL® Absorbable Hemostat

ACTIVE COMPARATOR

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Device: SURGICEL®

Interventions

EVARREST™ Sealant Matrix BIOLOGICAL

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.

Also known as: EVARREST™ Fibrin Sealant Patch

EVARREST™ Sealant Matrix

SURGICEL® DEVICE

SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.

Also known as: oxidized regenerated cellulose

SURGICEL® Absorbable Hemostat

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (10)

Clinical Investigation Site #32

Brussels, 1020, Belgium

Location

Investigative Site #30

Genk, Belgium

Location

Clinical Investigation Site #31

Ghent, Belgium

Location

Clinical Investigation Site #21

Birmingham, United Kingdom

Location

Clinical Investigation Site #22

Leeds, United Kingdom

Location

Clinical Investigation Site #20

Liverpool, United Kingdom

Location

Clinical Investigation Site #26

London, SE1 7EH, United Kingdom

Location

Clinical Investigation Site #23

London, United Kingdom

Location

Clinical Investigation Site #25

Nottingham, NG7 2UH, United Kingdom

Location

Clinical Investigation Site #24

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Franchise Medical Director
• Organization: Ethicon, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Richard Kocharian, MD, PhD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 28, 2014
• Study Start: July 1, 2014
• Primary Completion: October 27, 2021
• Study Completion: November 12, 2021
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

BE (3); GB (7)