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

March 20, 2026 updated by: Ethicon, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical.

Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery.

At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to [>=] 28 days from birth) to <1 year.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Chrildren's Hospital
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35222
        • University of Alabama Hospital
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mt Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 weeks to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 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
  2. 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.
  3. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
  4. Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification.

Exclusion Criteria:

  1. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
  2. Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;
  3. Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
  4. Subjects who are known, current alcohol and/or drug abusers
  5. Subjects admitted for trauma surgery
  6. Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
  7. 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
  8. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
  9. 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
  10. TBS with major arterial bleeding requiring suture or mechanical ligation;
  11. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EVARREST® Fibrin Sealant Patch
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
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.
Other Names:
  • EVARREST

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Time to Hemostasis
Time Frame: During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes
Time Frame: 4 minutes after TBS identification (during surgical procedure on Day 0)
Percentage of participants who achieved hemostatic success at 4 minutes was reported. A participant was considered hemostatic success at 4 minutes if the TBS was hemostatic at 4 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 4 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 4 minutes from TBS identification by carefully releasing manual compression and removing the surgical sponge (if used). 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.
4 minutes after TBS identification (during surgical procedure on Day 0)
Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes
Time Frame: 10 minutes after TBS identification (during surgical procedure on Day 0)
Percentage of participants who achieved hemostatic success at 10 minutes was reported. A participant was considered hemostatic success at 10 minutes if the TBS was hemostatic at 10 minutes, and there was no re-bleeding that required treatment (other than observation only) at the TBS from 10 minutes following the first TBS identification through final fascial closure. Hemostasis was assessed at 10 minutes from TBS identification and at initiation of final fascial closure. 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.
10 minutes after TBS identification (during surgical procedure on Day 0)
Percentage of Participants With No Re-bleeding at the TBS
Time Frame: During surgical procedure on Day 0 (from TBS identification to final fascial closure)
Percentage of participants with no re-bleeding at the TBS was reported. 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 final fascial closure)
Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS
Time Frame: 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 bleeding at the TBS was reported. 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. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality.
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
Time Frame: 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 at the TBS was reported. 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. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality.
From the day of surgical procedure (Day 0) up to 44-days post-surgery
Percentage of Participants With Re-treatment at the TBS
Time Frame: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Percentage of participants with re-treatment at the TBS was reported. 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.
From the day of surgical procedure (Day 0) up to 44-days post-surgery
Percentage of Participants With Adverse Events
Time Frame: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Percentage of participants with adverse events (including serious and non-serious) were reported. An adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug, without judgment about causality. Data is reported for participants with at least one AE. Participants having more than one AE are counted only once in this outcome measure.
From the day of surgical procedure (Day 0) up to 44-days post-surgery
Change From Baseline in Laboratory Parameter: Hemoglobin
Time Frame: From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)
Change from baseline in laboratory parameter (hemoglobin) was reported.
From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)
Change From Baseline in Laboratory Parameter: Hematocrit
Time Frame: From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)
Change from baseline in laboratory parameter (hematocrit; expressed as liters of cells per liter of blood) was reported.
From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)
Change From Baseline in Laboratory Parameter: Platelets
Time Frame: From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)
Change from baseline in laboratory parameter (platelets) was reported.
From baseline (within 21 days prior to procedure on Day 0) up to hospital discharge (up to 44-days post-surgery on Day 0)
Estimated Intraoperative Blood Loss
Time Frame: During surgical procedure on Day 0
Estimated intraoperative blood loss was reported.
During surgical procedure on Day 0
Number of Participants With Blood Products Transfusion
Time Frame: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Number of participants with blood products transfusion was reported.
From the day of surgical procedure (Day 0) up to 44-days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ethicon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIOS-16-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Efficacy and safety results related to the primary and secondary endpoints

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

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Locations

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