EVARREST Patch for Pediatric Surgical Bleeding

No longer recruiting at 4 trial locations

Overseen By Richard Kocharian, M.D., Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Ethicon, Inc.

Disqualifiers: Pregnancy, Nursing, Alcohol/drug abuse, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the EVARREST® Fibrin Sealant Patch to evaluate its safety and effectiveness in stopping mild to moderate bleeding during surgeries on the liver, abdomen, pelvis, or chest in children. The patch controls bleeding by adhering to the bleeding area and using special proteins to aid blood clotting. Children requiring these surgeries, with a mild to moderate bleeding site identified during the operation, may be eligible to participate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that the EVARREST® Fibrin Sealant Patch is safe for pediatric surgical bleeding?

Research has shown that the EVARREST Fibrin Sealant Patch is generally safe for use in surgeries. In clinical trials, more than 181 people aged 65 or older used this patch without major safety issues, indicating it is well-tolerated across different ages.

The patch has also been tested in challenging bleeding situations during surgery, proving safe and effective in controlling bleeding. No reports of safety problems directly linked to the patch suggest it has a good safety record.

Overall, the EVARREST patch appears to be a safe choice for managing surgical bleeding. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for surgical bleeding, which often involve sutures, staples, or traditional hemostatic agents, the EVARREST® Fibrin Sealant Patch is unique because it combines a flexible matrix with biological components like fibrinogen and thrombin. This innovative design allows it to actively promote clot formation and stabilize bleeding areas more effectively. Researchers are excited because the patch is bio-absorbable, meaning it integrates with the body and dissolves over time, potentially reducing complications and improving recovery times for pediatric patients.

What evidence suggests that the EVARREST Patch is effective for controlling surgical bleeding in pediatric patients?

Research has shown that the EVARREST Fibrin Sealant Patch, which participants in this trial will receive, effectively controls bleeding during surgeries, such as liver operations, by forming a stable clot. It has proven more effective than standard treatments in various surgical situations. In several studies, EVARREST outperformed usual care in managing bleeding during difficult surgeries. This patch combines a flexible material with natural components from human blood, aiding in quick clot formation and bleeding control. Overall, the EVARREST patch has proven effective in managing surgical bleeding. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: EVARREST® Fibrin Sealant Patch Experimental Treatment 1 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.

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

Published Research Related to This Trial

In a prospective study involving 72 patients undergoing cranial/spinal surgery, EVICEL® Fibrin Sealant effectively closed intraoperative cerebrospinal fluid (CSF) leaks in all but one case, demonstrating its efficacy as an adjunct to sutured dural repair.

The use of EVICEL® was associated with no adverse events related to the sealant, indicating a strong safety profile for patients undergoing serious neurosurgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(EVICEL) for Augmentation of Dural Closure: Results of a Preliminary Clinical Study. Gazzeri, R., Fiore, C., Galarza, M.[2019]

In a study involving 173 infants undergoing ECMO, the use of fibrin sealant alongside standard cauterization significantly reduced the risk of bleeding and the amount of shed blood compared to cauterization alone.

Fibrin sealant also led to a shorter duration of hemorrhage, making it an effective topical hemostatic agent for patients with coagulopathy who do not respond well to standard surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective, randomized evaluation of the efficacy of fibrin sealant as a topical hemostatic agent at the cannulation site in neonates undergoing extracorporeal membrane oxygenation. Atkinson, JB., Gomperts, ED., Kang, R., et al.[2019]

In a study of 40 patients undergoing carotid endarterectomy, the use of gelatine-resorcine-formol (GRF) glue significantly improved local haemostasis, reducing the time to achieve it from 22 minutes to just 11 minutes.

The application of GRF glue did not lead to any adverse effects during a follow-up period of 12 to 24 months, indicating its safety as a topical haemostatic agent without compromising the effectiveness of the ePTFE patch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gelatine-resorcine-formol glue as a sealant of ePTFE patch suture lines. Rittoo, D., Sintler, M., Burnley, S., et al.[2013]

In a study of 17 patients undergoing carotid endarterectomy, the use of topical fibrin sealant significantly reduced the median time to achieve haemostasis at the suture line from 19 minutes in the control group to 5.5 minutes in the treatment group (p < 0.005).

While the treatment group experienced lower operative blood loss (median 420ml) compared to the control group (median 550ml), this difference was not statistically significant, indicating that fibrin sealant effectively aids in achieving quicker haemostasis without increasing total operative time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibrin sealant reduces suture line bleeding during carotid endarterectomy: a randomised trial. Milne, AA., Murphy, WG., Reading, SJ., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Fibrin sealants, derived from human plasma, effectively enhance hemostasis during various surgical procedures, leading to reduced blood loss and lower postoperative complications, which can also decrease the need for blood transfusions.

Clinical studies indicate that the use of fibrin sealants significantly reduces blood loss and chest drain output compared to controls, making them particularly beneficial for patients with coagulopathies who are at higher risk for excessive bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of fibrin sealants in hemostasis. Mankad, PS., Codispoti, M.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 147 patients undergoing vascular surgery, the fibrin sealant EVICEL(™) significantly improved haemostasis at 4 minutes compared to manual compression, with 85% of patients achieving haemostasis versus 39% for manual compression.

The fibrin sealant also demonstrated lower treatment failure rates and was found to be safe, with similar rates of bleeding-related complications compared to manual compression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. Chalmers, RT., Darling Iii, RC., Wingard, JT., et al.[2016]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of fibrin sealant in reducing hemorrhage after a loop electrosurgical excision procedure. Kim, K., Park, SI., Kim, BJ., et al.[2012]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02227992

The EVARREST® Paediatric Mild/Moderate Liver and Soft ... The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in ...

2. withpower.com withpower.com/trial/phase-3-hemorrhage-2-2018-bbfa1

EVARREST Patch 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 ...

3. fda.gov fda.gov/media/85265/download

HIGHLIGHTS OF PRESCRIBING INFORMATION ... EVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5036832/

A hospital cost analysis of a fibrin sealant patch in soft ... Evarrest® is a novel fibrin sealant patch that has demonstrated high hemostatic efficacy compared with standard of care across bleeding ...

5. jnjmedtech.com jnjmedtech.com/en-US/product/evarrest-fibrin-sealant-patch

EVARREST™ Fibrin Sealant Patch - J&J MedTech EVARREST demonstrated superior hemostatic efficacy in 4 randomized controlled clinical trials across a spectrum of challenging bleeding situations and surgical ...