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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Controlling Mild to Moderate Bleeding During Surgery

Intervention / Treatment
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* Biological: EVARREST® Fibrin Sealant Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric subjects aged ≥28 days (≥1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; i) The first 31 subjects to be enrolled will be subjects aged ≥1 years to <18 years. ii) The next 4 subjects to be enrolled will be subjects aged ≥28 days to <1 year. The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written Informed Consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. 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. Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon; Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification. Exclusion Criteria: Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products; Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing; Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor; Subjects who are known, current alcohol and/or drug abusers Subjects admitted for trauma surgery Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected) TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and pressure during healing and absorption of the product TBS with major arterial bleeding requiring suture or mechanical ligation; Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVARREST® Fibrin Sealant Patch<br>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. | Biological: EVARREST® Fibrin Sealant Patch<br>* 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.<br>* Other names: EVARREST;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute time to hemostasis | The absolute time to hemostasis, defined as the absolute time elapsed from TBS identification to the last moment in time at which detectable bleeding at the TBS is observed. | Intraoperative from TBS identification to the last moment in time at which no detectable bleeding at the TBS is observed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic success at 4 minutes | Proportion of subjects achieving hemostatic success at 4 minutes following Target Bleeding Site (TBS) identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure. | Intraoperative, 4 minutes after TBS identification | 
| Hemostatic success at 10 minutes | Proportion of subjects achieving hemostatic success at 10 minutes following TBS identification and no bleeding requiring treatment at the TBS any time prior to final fascial closure. | Intraoperative, 10 minutes after TBS identification | 
| No re-bleeding at the TBS | Proportion of subjects with no re-bleeding at the TBS. | Intraoperative, from TBS identification to final fascial closure | 
| Incidence of adverse events that are potentially related to bleeding at the TBS | Incidence of adverse events that are potentially related to bleeding at the TBS. | Intraoperative to 30 (+/- 14) days | 
| Incidence of adverse events that are potentially related to thrombotic events | Incidence of adverse events that are potentially related to thrombotic events. | Intraoperative to 30 (+/- 14) days | 
| Incidence of re-treatment at the TBS |  | Intraoperative, from TBS identification to final fascial closure | 
| Incidence of Adverse Events |  | Intraoperative to 30 (+/- 14) days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding, hemostasis, re-bleeding, hemostatic