The EVARREST® Fibrin Sealant Patch Liver Study

Phase 3

Completed

Interventions: Biological: EVARREST® Fibrin Sealant Patch
Other: Standard of Care (SoC)

Brief Summary: To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Recruitment & Eligibility

Inclusion Criteria

Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion Criteria

Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
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;
Subjects admitted for trauma surgery;
Subject is a transplant patient for fulminant hepatic failure
Subject with TBS within an actively infected field;
Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
Subjects who are known, current alcohol and / or drug abusers;
Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
Female subjects who are pregnant or nursing.

Arm && Interventions

Group	Intervention	Description
EVARREST® Fibrin Sealant Patch	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 two biological components (Human Fibrinogen and Human Thrombin).
Standard of Care (SoC)	Standard of Care (SoC)	SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).

Primary Outcome Measures

Name	Time	Method
Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization	Intraoperative, 4 minutes following randomization	Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.

Secondary Outcome Measures

Name	Time	Method
Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization	Intraoperative, 10 minutes following randomization	Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.
Incidence of Re-bleeding Events From the TBS During the Study Follow-up	Up to 60-days following surgery
Incidence of Adverse Events (AEs)	Up to 60-days following surgery
Incidence of Adverse Events That Were Potentially Related to Thrombotic Events	Up to 60-days following surgery	Number of participants with adverse events that were potentially related to thrombic events
Absolute Time to Hemostasis	Intraoperative, an average of 4.2 minutes following randomization	The absolute time to achieve hemostasis at or after 4 minutes from randomization.

Locations (17): Clinical Investigation Site #13
🇺🇸
Birmingham, Alabama, United States
Clinical Investigation Site #10
🇺🇸
Augusta, Georgia, United States
Clinical Investigation Site #16
🇺🇸
Chicago, Illinois, United States
Clinical Investigation Site #12
🇺🇸
Chicago, Illinois, United States
Clinical Investigation Site #15
🇺🇸
New Orleans, Louisiana, United States
Clinical Investigation Site #9
🇺🇸
St. Louis, Missouri, United States
Clinical Investigation Site #11
🇺🇸
New York, New York, United States
Clinical Investigation Site #14
🇺🇸
New York, New York, United States
Clinical Investigation Site #8
🇺🇸
Philadelphia, Pennsylvania, United States
Clinical Investigation Site #17
🇺🇸
Pittsburgh, Pennsylvania, United States
Clinical Investigation Site #3
🇦🇺
Melbourne, Australia
Clinical Investigation Site #2
🇦🇺
Woodville South, Australia
Clinical Investigation Site #7
🇬🇧
Cambridge, United Kingdom
Clinical Investigation Site #1
🇳🇿
Auckland, New Zealand
Clinical Investigation Site #4
🇬🇧
Edinburgh, United Kingdom
Clinical Investigation Site #5
🇬🇧
Leeds, United Kingdom
Clinical Investigation Site #6
🇬🇧
Birmingham, United Kingdom