EVARREST™ Fibrin Sealant Patch Post-Market Study

Phase 4

Completed

Interventions: Other: Standard of Care
Biological: EVARREST™ Fibrin Sealant Patch

Brief Summary: 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: 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.

Recruitment & Eligibility

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;

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.
EVARREST™ Fibrin Sealant Patch	EVARREST™ Fibrin Sealant Patch	EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.

Primary Outcome Measures

Name	Time	Method
Safety Parameter - Incidence of Thromboembolic Events	Surgery up until the 30 day follow-up	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.
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)	Surgery up until the 30 day follow-up	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.
Safety Parameter - Incidence of Increase Blood Fibrinogen Level	Surgery up until the 30 day follow-up	Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.