Controlling Mild to Moderate Bleeding During SurgeryPhase 3NCT03255174
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
A Phase 3 study testing EVARREST® Fibrin Sealant Patch in people with Controlling Mild to Moderate Bleeding During Surgery, run by Ethicon, Inc. at 5 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 28 days to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Controlling Mild to Moderate Bleeding During Surgery
- What is being tested?
- EVARREST® Fibrin Sealant Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Mar 2018to 14 Feb 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom3 sites
Birmingham Chrildren's Hospital
Birmingham, B4 6NH
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP
Southampton University Hospital
Southampton, SO16 6YD
United States2 sites
University of Alabama Hospital
Birmingham, Alabama, 35222
icahn School of Medicine at Mt Sinai
New York, New York, 10029
About this study
Official title: 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.
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.
- Being tested
- EVARREST® Fibrin Sealant Patch
- Keywords
- Bleeding, hemostasis, re-bleeding, hemostatic
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVARREST® Fibrin Sealant PatchBiological
Also called EVARREST
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: EVARREST® Fibrin Sealant Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During surgical procedure on Day 0
Number of Participants With Blood Products Transfusion
Number of participants with blood products transfusion was reported.
Measured: From the day of surgical procedure (Day 0) up to 44-days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start20 Mar 2018
- Primary completion22 Jan 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Controlling Mild to Moderate Bleeding During SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255174
- Sponsor's protocol ID
- BIOS-16-001
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2017
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Efficacy and safety results related to the primary and secondary endpoints
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03255174
- Acronym / sponsor ID
- BIOS-16-001
- Keywords
- Bleeding, hemostasis, re-bleeding, hemostatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVARREST® Fibrin Sealant Patch | Experimental | Biological: EVARREST® Fibrin Sealant PatchEVARREST 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. |
Who may qualify
- Ages
- 28 days to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVARREST® Fibrin Sealant PatchAlso: EVARRESTEVARREST 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 |
Primary outcome
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.
12 secondary outcomes
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 10 Minutes
Time frame: 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 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 Thrombotic Events
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
Time frame: 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
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: 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: 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)
Estimated Intraoperative Blood Loss
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Efficacy and safety results related to the primary and secondary endpoints
Related trials for Controlling Mild to Moderate Bleeding During Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EVARREST® Fibrin Sealant Patch in people with Controlling Mild to Moderate Bleeding During Surgery, run by Ethicon, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.