The EVARREST® Fibrin Sealant Patch Liver Study

NCT ID: NCT01993888

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-09-30

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.

Conditions

Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

EVARREST® Fibrin Sealant Patch

Intervention Type: BIOLOGICAL

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).

Group Type: OTHER

Standard of Care (SoC)

Intervention Type: OTHER

Interventions

EVARREST® Fibrin Sealant Patch

Intervention Type: BIOLOGICAL

Standard of Care (SoC)

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Kocharian, MD

Role: STUDY_DIRECTOR

Ethicon, Inc.

Locations

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 #1

Auckland, , New Zealand

Clinical Investigation Site #6

Birmingham, , United Kingdom

Clinical Investigation Site #7

Cambridge, , United Kingdom

Clinical Investigation Site #4

Edinburgh, , United Kingdom

Clinical Investigation Site #5

Leeds, , United Kingdom

Countries

United States; Australia; New Zealand; United Kingdom

References

Koea JB, Batiller J, Aguirre N, Shen J, Kocharian R, Bochicchio G, Garden OJ. A multicentre, prospective, randomized, controlled trial comparing EVARREST fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection. HPB (Oxford). 2016 Mar;18(3):221-8. doi: 10.1016/j.hpb.2015.12.006. Epub 2016 Feb 1.

Reference Type: RESULT

PMID: 27017161 (View on PubMed)

Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.

Reference Type: DERIVED

PMID: 26636489 (View on PubMed)

Other Identifiers

2013-002535-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIOS-13-005

Identifier Type: -

Identifier Source: org_study_id