New patch stops bleeding fast in Kids' surgeries
NCT ID NCT03255174
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Controlling mild to moderate bleeding during surgery are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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