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.
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.
Enrollment will be staggered by age. The first group will include 31 subjects 1 years to <18 years of age and the subsequent group will include 4 subjects from 1 month ( 28 days from birth) to <1 years of age. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrollment.
At least thirty-five (35) qualified pediatric subjects with an appropriate mild or moderate bleeding TBS will be enrolled in this study.
|Treatment||EVARREST® Fibrin Sealant Patch|
|Clinical Study Identifier||NCT03255174|
|Last Modified on||15 January 2021|
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