NCT03255174

The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study

A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Pediatric Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 28 Days – 17 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue for which standard methods of achieving hemostasis are ineffective or impractical. Eligible subjects will be treated with EVARREST. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery. At least thirty-five pediatric subjects with an appropriate mild or moderate bleeding target bleeding site (TBS) will be enrolled in this study. The age of the subjects enrolled in the study will be from 1 month to less than (\<) 18 years. This will include a minimum of 4 subjects aged 1 month (greater than or equal to \[\>=\] 28 days from birth) to \<1 year.

Conditions

• Controlling Mild to Moderate Bleeding During Surgery

Interventions

Type	Name	Description
BIOLOGICAL	EVARREST® Fibrin Sealant Patch	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.

Timeline

• Start date: 2018-03-20
• Primary completion: 2025-01-22
• Completion: 2025-02-14
• First posted: 2017-08-21
• Last updated: 2026-04-08
• Results posted: 2026-04-08

Locations

5 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study