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New patch stops bleeding fast in Kids' surgeries

NCT ID NCT03255174

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a patch called EVARREST that helps stop mild to moderate bleeding during open surgery in children. The patch contains natural proteins that help blood clot. In 35 children, the patch stopped bleeding quickly, often within 4 minutes. The results suggest it is a safe and effective tool for surgeons.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EVARREST Fibrin Sealant Patch (a patch with human fibrinogen and thrombin to stop bleeding)
What this could lead to
If successful, this could provide a safe and effective way to control bleeding during surgery in children, reducing the need for other methods.
What could go wrong
This is a small, completed Phase 3 trial with only 35 participants. Results may not apply to all children or all types of bleeding. There is always a risk of allergic reactions or the patch not working.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

35 people

The number who actually took part.

Started

Mar 2018

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

28 days to 17 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 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

  • University of Alabama Hospital

    Birmingham, Alabama, 35222, United States

  • icahn School of Medicine at Mt Sinai

    New York, New York, 10029, United States