CompletedNCT03255174Updated Apr 8, 2026Results posted

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

A Phase 3 interventional study of EVARREST® Fibrin Sealant Patch in Controlling Mild to Moderate Bleeding During Surgery, sponsored by Ethicon, Inc.. Completed at 5 sites in 2 countries. Open to participants aged 28 Days to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Ethicon, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 35
Allocation: Not applicable
Ages: 28 Days to 17 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Controlling Mild to Moderate Bleeding During Surgery

Browse trials for

Hemorrhage 2,996

Keywords

Bleeding, hemostasis, re-bleeding, hemostatic

Who can participate

Ages eligible: 28 Days to 17 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

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, 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

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

Interventions

BiologicalEVARREST® 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.
Also known as: EVARREST

What researchers measure

Primary outcomes

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

Secondary outcomes

Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes
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.
Time frame: 4 minutes after TBS identification (during surgical procedure on Day 0)
Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes
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.
Time frame: 10 minutes after TBS identification (during surgical procedure on Day 0)
Percentage of Participants With No Re-bleeding at the TBS
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.
Time frame: 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
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.
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
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.
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
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.
Time frame: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Percentage of Participants With Adverse Events
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.
Time frame: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Change From Baseline in Laboratory Parameter: Hemoglobin
Change from baseline in laboratory parameter (hemoglobin) was reported.
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
Change from baseline in laboratory parameter (hematocrit; expressed as liters of cells per liter of blood) was reported.
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
Change from baseline in laboratory parameter (platelets) was reported.
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)
Estimated Intraoperative Blood Loss
Estimated intraoperative blood loss was reported.
Time frame: During surgical procedure on Day 0
Number of Participants With Blood Products Transfusion
Number of participants with blood products transfusion was reported.
Time frame: From the day of surgical procedure (Day 0) up to 44-days post-surgery

Results

Posted Apr 8, 2026

Participant flow

Participant flow — Overall Study
Milestone	EVARREST Fibrin Sealant Patch
Started	35
Full analysis set	31
Completed	35
Not completed	0

Outcome measures

PrimaryAbsolute 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.

Time frame:: During surgical procedure on Day 0 (from TBS identification to the last moment in time at which detectable bleeding at TBS observed)
Reported as:: Median · Minutes

Absolute Time to Hemostasis
Minutes	EVARREST Fibrin Sealant Patch
Absolute Time to Hemostasis	4.00 (4.00 to 4.00)

SecondaryPercentage of Participants Who Achieved Hemostatic Success at 4 Minutes

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.

Time frame:: 4 minutes after TBS identification (during surgical procedure on Day 0)
Reported as:: Number · Percentage of participants

Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants Who Achieved Hemostatic Success at 4 Minutes	77.4 (58.90 to 90.41)

SecondaryPercentage of Participants Who Achieved Hemostatic Success at 10 Minutes

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.

Time frame:: 10 minutes after TBS identification (during surgical procedure on Day 0)
Reported as:: Number · Percentage of participants

Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants Who Achieved Hemostatic Success at 10 Minutes	93.5 (78.58 to 99.21)

SecondaryPercentage of Participants With No Re-bleeding at the TBS

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.

Time frame:: During surgical procedure on Day 0 (from TBS identification to final fascial closure)
Reported as:: Number · Percentage of participants

Percentage of Participants With No Re-bleeding at the TBS
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants With No Re-bleeding at the TBS	96.8

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

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.

Time frame:: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Reported as:: Number · Percentage of participants

Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants With Adverse Events That Were Potentially Related to Bleeding at the TBS	5.7

SecondaryPercentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events

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.

Time frame:: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Reported as:: Number · Percentage of participants

Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants With Adverse Events That Were Potentially Related to Thrombotic Events	0

SecondaryPercentage of Participants With Re-treatment at the TBS

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.

Time frame:: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Reported as:: Number · Percentage of participants

Percentage of Participants With Re-treatment at the TBS
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants With Re-treatment at the TBS	25.7

SecondaryPercentage of Participants With Adverse Events

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.

Time frame:: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Reported as:: Number · Percentage of participants

Percentage of Participants With Adverse Events
Percentage of participants	EVARREST Fibrin Sealant Patch
Percentage of Participants With Adverse Events	68.6

SecondaryChange From Baseline in Laboratory Parameter: Hemoglobin

Change from baseline in laboratory parameter (hemoglobin) was reported.

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)
Reported as:: Mean · Grams per liter (g/L)

Change From Baseline in Laboratory Parameter: Hemoglobin
Grams per liter (g/L)	EVARREST Fibrin Sealant Patch
Change From Baseline in Laboratory Parameter: Hemoglobin	-5.59 ± 16.353

SecondaryChange From Baseline in Laboratory Parameter: Hematocrit

Change from baseline in laboratory parameter (hematocrit; expressed as liters of cells per liter of blood) was reported.

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)
Reported as:: Mean · Liters per liter (L/L)

Change From Baseline in Laboratory Parameter: Hematocrit
Liters per liter (L/L)	EVARREST Fibrin Sealant Patch
Change From Baseline in Laboratory Parameter: Hematocrit	-0.02 ± 0.048

SecondaryChange From Baseline in Laboratory Parameter: Platelets

Change from baseline in laboratory parameter (platelets) was reported.

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)
Reported as:: Mean · 10^9 cells per liter

Change From Baseline in Laboratory Parameter: Platelets
10^9 cells per liter	EVARREST Fibrin Sealant Patch
Change From Baseline in Laboratory Parameter: Platelets	-18.87 ± 130.724

SecondaryEstimated Intraoperative Blood Loss

Estimated intraoperative blood loss was reported.

Time frame:: During surgical procedure on Day 0
Reported as:: Mean · Milliliters (mL)

Estimated Intraoperative Blood Loss
Milliliters (mL)	EVARREST Fibrin Sealant Patch
Estimated Intraoperative Blood Loss	81.9 ± 112.00

SecondaryNumber of Participants With Blood Products Transfusion

Number of participants with blood products transfusion was reported.

Time frame:: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Reported as:: Count of participants · Participants

Number of Participants With Blood Products Transfusion
Participants	EVARREST Fibrin Sealant Patch
Number of Participants With Blood Products Transfusion	11

Adverse events

Collected over From the day of surgical procedure (Day 0) up to 44-days post-surgery. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
EVARREST Fibrin Sealant Patch	0/35 (0%)	9/35 (25.7%)	21/35 (60%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	EVARREST Fibrin Sealant Patch
Febrile neutropeniaBlood and lymphatic system disorders	3/35
PyrexiaGeneral disorders	1/35
Catheter site infectionInfections and infestations	1/35
Lower respiratory tract infectionInfections and infestations	1/35
Respiratory syncytial virus infectionInfections and infestations	1/35
Post procedural bile leakInjury, poisoning and procedural complications	1/35
Procedural painInjury, poisoning and procedural complications	1/35
Procedural vomitingInjury, poisoning and procedural complications	1/35
DehydrationMetabolism and nutrition disorders	1/35
SyncopeNervous system disorders	1/35

Most frequent other events

Showing 10 of 69

Most frequent other events
Event	EVARREST Fibrin Sealant Patch
Procedural painInjury, poisoning and procedural complications	11/35
HypertensionVascular disorders	11/35
TachycardiaCardiac disorders	10/35
ConstipationGastrointestinal disorders	10/35
VomitingGastrointestinal disorders	8/35
PyrexiaGeneral disorders	8/35
Abdominal painGastrointestinal disorders	5/35
Blood potassium decreasedInvestigations	4/35
Oxygen saturation decreasedInvestigations	4/35
HypotensionVascular disorders	4/35

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	EVARREST Fibrin Sealant Patch
<=18 years	35
Between 18 and 65 years	0
>=65 years	0

Age, Continuous
Age, Continuous(Years)	EVARREST Fibrin Sealant Patch
Mean	4.59 ± 4.341

Sex: Female, Male
Sex: Female, Male(Participants)	EVARREST Fibrin Sealant Patch
Female	15
Male	20

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	EVARREST Fibrin Sealant Patch
Hispanic or Latino	2
Not Hispanic or Latino	33
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	EVARREST Fibrin Sealant Patch
American Indian or Alaska Native	0
Asian	3
Native Hawaiian or Other Pacific Islander	0
Black or African American	9
White	20
More than one race	0
Unknown or Not Reported	3

Study locations

5 sites

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

References and documents

Study documents

Study protocol · Nov 2, 2023
Statistical analysis plan · Feb 27, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Efficacy and safety results related to the primary and secondary endpoints

Registry details

Key details

Study ID: NCT03255174
Lead sponsor: Ethicon, Inc.
Responsible party: Sponsor
First posted: Aug 21, 2017
Start date: Mar 20, 2018
Primary completion: Jan 22, 2025
Completion: Feb 14, 2025
Results posted: Apr 8, 2026
Last update: Apr 8, 2026

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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