EVARREST Patch for Pediatric Surgical Bleeding

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

35 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{3 5 7 8 9}

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

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

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

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

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.

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]

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]

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]

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]

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 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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

A hospital cost analysis of a fibrin sealant patch in soft tissue and hepatic surgical bleeding. [2020]

2. England 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. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of fibrin sealant in reducing hemorrhage after a loop electrosurgical excision procedure. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

The role of fibrin sealants in hemostasis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

(EVICEL) for Augmentation of Dural Closure: Results of a Preliminary Clinical Study. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of tranexamic acid-free fibrin sealant during vascular surgical procedures. [2016]

7. United States 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. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

Gelatine-resorcine-formol glue as a sealant of ePTFE patch suture lines. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Fibrin sealant reduces suture line bleeding during carotid endarterectomy: a randomised trial. [2019]