The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study

NCT03255174 | Completed Phase 3 Results FDA Drug

• 1 other identifier: BIOS-16-001
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 5

Brief Summary

The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.

Conditions

Controlling Mild to Moderate Bleeding During Surgery

Keywords

Bleeding, hemostasis, re-bleeding, hemostatic

Outcome Measures

Primary Outcomes (1)

• Absolute Time to Hemostasis

  Hemostasis was defined as no detectable bleeding at the TBS. Absolute time to hemostasis was defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS was observed. TBS was defined as the first accessible mild or moderate bleeding site identified in the hepatic parenchyma or soft tissue, where conventional methods of controlling bleeding were ineffective or impractical and was amenable to manual compression.

  During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)

Secondary Outcomes (12)

• Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes

  4 minutes after TBS identification (during surgical procedure on Day 0)

• Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes

  10 minutes after TBS identification (during surgical procedure on Day 0)

• Percentage of Participants With No Re-bleeding at the TBS

  During surgical procedure on Day 0 (from TBS identification to final fascial closure)

• Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS

  From the day of surgical procedure (Day 0) up to 44-days post-surgery

• Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events

  From the day of surgical procedure (Day 0) up to 44-days post-surgery

Study Arms (1)

EVARREST® Fibrin Sealant Patch

EXPERIMENTAL

EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.

Biological: EVARREST® Fibrin Sealant Patch

Interventions

EVARREST® Fibrin Sealant Patch BIOLOGICAL

EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.

Also known as: EVARREST

EVARREST® Fibrin Sealant Patch

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric subjects aged ≥28 days (≥1 month) to \<18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; i) A minimum of 4 subjects to be enrolled will be 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 pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the pediatric 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 TBS identification.

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, of childbearing age (i.e. adolescent), who are pregnant or nursing;
• Subject is currently participating or plan to participate in any other investigational device or drug study 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
• Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period
• 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 EVARREST 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 (5)

University of Alabama Hospital

Birmingham, Alabama, 35222, United States

Location

icahn School of Medicine at Mt Sinai

New York, New York, 10029, United States

Location

Birmingham Chrildren's Hospital

Birmingham, B4 6NH, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Southampton University Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: SR. FRANCHISE MEDICAL DIRECTOR
• Organization: Ethicon, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: August 21, 2017
• Study Start: March 20, 2018
• Primary Completion: January 22, 2025
• Study Completion: February 14, 2025
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (2); GB (3)