35 Participants Needed

EVARREST Patch for Pediatric Surgical Bleeding

Recruiting at 4 trial locations
EB
RK
Overseen ByRichard Kocharian, M.D., Ph.D.
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Ethicon, Inc.
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the EVARREST treatment for pediatric surgical bleeding?

Research shows that the EVARREST Fibrin Sealant Patch is effective in controlling bleeding during surgeries, such as liver resections, by forming a stable clot to stop bleeding. Fibrin sealants, like EVARREST, have been used successfully in various surgeries to reduce blood loss and improve recovery.12345

Is the EVARREST Patch safe for use in humans?

The EVARREST Fibrin Sealant Patch has been studied for safety in controlling bleeding during liver surgeries, and no specific safety concerns were reported in the available research.12356

How is the EVARREST Patch treatment for pediatric surgical bleeding different from other treatments?

The EVARREST Patch is unique because it combines a fibrin sealant with a patch to control bleeding during surgery. This combination allows it to adhere to tissue and provide a physical barrier, which is different from other treatments that may only use a liquid sealant or rely on traditional methods like sutures.35789

Eligibility Criteria

This trial is for pediatric patients aged 1 month to <18 years needing non-emergency surgery for mild or moderate liver and soft tissue bleeding. It's not for kids with major arterial bleeding, pregnant adolescents, drug abusers, trauma surgery patients, those with certain pre-operative conditions, recent or upcoming COVID-19 vaccinations, participation in other trials without approval, intolerance to blood products or infected surgical sites.

Inclusion Criteria

You are able to press the trial treatment firmly for at least 4 minutes after it is applied.
I am a baby aged between 28 days and less than 1 year.
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
See 5 more

Exclusion Criteria

I cannot tolerate blood products or components of the study product.
I am a woman of childbearing age and I am not pregnant or nursing.
I have been or will be vaccinated for COVID-19 around my surgery.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Eligible subjects will be treated with EVARREST Fibrin Sealant Patch during surgery to control mild or moderate bleeding

Intraoperative
1 visit (in-person, during surgery)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and laboratory test abnormalities

30 days (+/- 14 days) post-surgery
Post-operative monitoring through discharge and follow-up visit

Treatment Details

Interventions

  • EVARREST® Fibrin Sealant Patch
Trial Overview The study tests the safety and effectiveness of EVARREST Fibrin Sealant Patch as an additional method to control bleeding during certain types of open surgeries in children. The patch is applied directly to the site of bleeding during the procedure.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EVARREST® Fibrin Sealant PatchExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ethicon, Inc.

Lead Sponsor

Trials
95
Recruited
62,300+

Tim Schmid

Ethicon, Inc.

Chief Executive Officer since 2023

Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom

Nancy Sabin

Ethicon, Inc.

Chief Medical Officer

MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University

Findings from Research

The Evarrest® fibrin sealant patch demonstrated significant cost savings in treating surgical bleeding, with a predicted reduction of $54 per patient compared to standard care in a surgical analysis and $2,846 in a broader hospital analysis.
In coagulopathic patients, the fibrin sealant patch showed even greater potential for cost savings, with reductions of $3,233 in surgical costs and $9,287 in hospital costs, highlighting its efficacy in managing complex bleeding situations.
A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding.Corral, M., Ferko, N., Hogan, A., et al.[2020]
The EVARREST™ Fibrin Sealant Patch (FP) was found to be significantly more effective than standard care in achieving haemostasis within 4 minutes after liver surgery, with 96% success compared to 46% for standard care (p < 0.001).
The FP demonstrated consistent efficacy across both anatomic and non-anatomic liver resections, while the safety profile was comparable to standard care, with a low incidence of treatment-related adverse events.
A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection.Koea, JB., Batiller, J., Aguirre, N., et al.[2018]
In a study of 344 patients who underwent loop electrosurgical excision procedure (LEEP), the use of fibrin sealant significantly reduced the incidence of severe secondary hemorrhage (SSH) from 8% to 3%.
Multivariate analysis confirmed that fibrin sealant use was associated with a lower risk of SSH, with an odds ratio of 0.328, indicating it is an effective intervention to enhance post-operative safety.
Efficacy of fibrin sealant in reducing hemorrhage after a loop electrosurgical excision procedure.Kim, K., Park, SI., Kim, BJ., et al.[2012]

References

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding. [2020]
A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection. [2018]
Efficacy of fibrin sealant in reducing hemorrhage after a loop electrosurgical excision procedure. [2012]
The role of fibrin sealants in hemostasis. [2019]
(EVICEL) for Augmentation of Dural Closure: Results of a Preliminary Clinical Study. [2019]
Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. [2016]
Prospective, randomized evaluation of the efficacy of fibrin sealant as a topical hemostatic agent at the cannulation site in neonates undergoing extracorporeal membrane oxygenation. [2019]
Gelatine-resorcine-formol glue as a sealant of ePTFE patch suture lines. [2013]
Fibrin sealant reduces suture line bleeding during carotid endarterectomy: a randomised trial. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security