EVARREST™ Fibrin Sealant Patch Post-Market Study

Study Overview
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Brief Summary
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The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.

Detailed Description
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This is a randomized, controlled single-center study observing the clinical utility of EVARREST™ against standard of care (SoC) in controlling soft tissue bleeding. Standard of care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care. All subjects will be followed post-operatively through discharge and at 30 (+/-14) days. Approximately 150 qualified subjects undergoing intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery requiring adjunctive support for hemostasis for soft tissue bleeding will be enrolled in the study. Subjects will be randomized on a 1:1 basis, EVARREST™ vs. SoC.

Official Title
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A Non-Investigational Post-Market Trial Using EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis in Soft Tissue Bleeding During Intra-Abdominal, Retroperitoneal, Pelvic and Non-Cardiac Thoracic Surgery

Conditions
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Hemorrhage, Soft Tissue Bleeding

Intervention / Treatment
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* Biological: EVARREST™ Fibrin Sealant Patch
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects ≥18 years of age, requiring an elective or urgent, open intra-abdominal, retroperitoneal, pelvic or non-cardiac thoracic surgical procedures; Subjects or legally authorized representative must be willing to participate in the study and provide written informed consent. Presence of an appropriate Target Bleeding Site as identified intra-operatively by the surgeon; Exclusion Criteria: Subjects with known intolerance to blood products or to one of the components of EVARREST™ or unwilling to receive blood products; Female subjects who are pregnant or nursing. TBS is from a large defect in an artery or vein where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ to blood flow and/or pressure during absorption of the product; TBS with major arterial bleeding requiring suture or mechanical ligation; TBS within a contaminated or infected area of the body; Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EVARREST™ Fibrin Sealant Patch<br>EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human 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, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.<br>|
| Other: Standard of Care<br>Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat. | Other: Standard of Care<br>* Standard of Care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Parameter - Incidence of Thromboembolic Events | Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started. | Surgery up until the 30 day follow-up | 
| Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS) | Number of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started. | Surgery up until the 30 day follow-up | 
| Safety Parameter - Incidence of Increase Blood Fibrinogen Level | Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started. | Surgery up until the 30 day follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostasis