The EVARREST® Fibrin Sealant Patch Liver Study

NCT01993888 | Completed Phase 3 Results DMC

• 2 other identifiers: BIOS-13-0052013-002535-24
• Study Type: interventional
• Target: 102
• Locations: 4 countries
• Sites: 17

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

Keywords

Hepatobiliary Surgery

Outcome Measures

Primary Outcomes (1)

• Hemostasis at the Target Bleeding Site (TBS) at 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.

  Intraoperative, 4 minutes following randomization

Secondary Outcomes (5)

• Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization

  Intraoperative, 10 minutes following randomization

• Absolute Time to Hemostasis

  Intraoperative, an average of 4.2 minutes following randomization

• 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

Study Arms (2)

EVARREST® Fibrin Sealant Patch

EXPERIMENTAL

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).

Biological: EVARREST® Fibrin Sealant Patch

Standard of Care (SoC)

OTHER

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).

Other: Standard of Care (SoC)

Interventions

EVARREST® Fibrin Sealant Patch BIOLOGICAL

EVARREST® Fibrin Sealant Patch

Standard of Care (SoC) OTHER

Standard of Care (SoC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (17)

Clinical Investigation Site #13

Birmingham, Alabama, 35294, United States

Location

Clinical Investigation Site #10

Augusta, Georgia, 30912, United States

Location

Clinical Investigation Site #16

Chicago, Illinois, 60611, United States

Location

Clinical Investigation Site #12

Chicago, Illinois, 60637, United States

Location

Clinical Investigation Site #15

New Orleans, Louisiana, 70121, United States

Location

Clinical Investigation Site #9

St Louis, Missouri, 63110, United States

Location

Clinical Investigation Site #11

New York, New York, 10032, United States

Location

Clinical Investigation Site #14

New York, New York, 10065, United States

Location

Clinical Investigation Site #8

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Investigation Site #17

Pittsburgh, Pennsylvania, 15213, United States

Location

Clinical Investigation Site #3

Melbourne, 3004, Australia

Location

Clinical Investigation Site #2

Woodville South, 5011, Australia

Location

Clinical Investigation Site #1

Auckland, 93-503, New Zealand

Location

Clinical Investigation Site #6

Birmingham, B15 2TH, United Kingdom

Location

Clinical Investigation Site #7

Cambridge, CB2 0QQ, United Kingdom

Location

Clinical Investigation Site #4

Edinburgh, EH16 4SA, United Kingdom

Location

Clinical Investigation Site #5

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 27017161 RESULT

• 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.

  PMID: 26636489 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

* The study could not be blinded due to difference in groups * The efficacy was limited to one bleeding site to minimize the variability in assessing the primary endpoint * The sample may not be sufficient to detect a difference in clinical outcomes.

Results Point of Contact

• Title: Senior Director of Ethicon Clinical R&D
• Organization: Ethicon, Inc.

jbatill2@its.jnj.com

908-218-2492

Study Officials

• Richard Kocharian, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-04

Locations

US (10); NZ (1); AU (2); GB (4)