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The EVARREST® Fibrin Sealant Patch Liver Study

Primary Purpose

Hemorrhage

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EVARREST® Fibrin Sealant Patch
Standard of Care (SoC)
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring Hepatobiliary Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinical Investigation Site #13
  • Clinical Investigation Site #10
  • Clinical Investigation Site #16
  • Clinical Investigation Site #12
  • Clinical Investigation Site #15
  • Clinical Investigation Site #9
  • Clinical Investigation Site #11
  • Clinical Investigation Site #14
  • Clinical Investigation Site #8
  • Clinical Investigation Site #17
  • Clinical Investigation Site #3
  • Clinical Investigation Site #2
  • Clinical Investigation Site #1
  • Clinical Investigation Site #6
  • Clinical Investigation Site #7
  • Clinical Investigation Site #4
  • Clinical Investigation Site #5

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

EVARREST® Fibrin Sealant Patch

Standard of Care (SoC)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hemostasis at the Target Bleeding Site (TBS) at 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.
Absolute Time to Hemostasis
The absolute time to achieve hemostasis at or after 4 minutes from randomization.
Incidence of Re-bleeding Events From the TBS During the Study Follow-up
Incidence of Adverse Events (AEs)
Incidence of Adverse Events That Were Potentially Related to Thrombotic Events
Number of participants with adverse events that were potentially related to thrombic events

Full Information

First Posted
November 19, 2013
Last Updated
May 31, 2016
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01993888
Brief Title
The EVARREST® Fibrin Sealant Patch Liver Study
Official Title
A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
Hepatobiliary Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVARREST® Fibrin Sealant Patch
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care (SoC)
Arm Type
Other
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
EVARREST® Fibrin Sealant Patch
Intervention Type
Other
Intervention Name(s)
Standard of Care (SoC)
Primary Outcome Measure Information:
Title
Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
Description
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.
Time Frame
Intraoperative, 4 minutes following randomization
Secondary Outcome Measure Information:
Title
Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization
Description
Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.
Time Frame
Intraoperative, 10 minutes following randomization
Title
Absolute Time to Hemostasis
Description
The absolute time to achieve hemostasis at or after 4 minutes from randomization.
Time Frame
Intraoperative, an average of 4.2 minutes following randomization
Title
Incidence of Re-bleeding Events From the TBS During the Study Follow-up
Time Frame
Up to 60-days following surgery
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 60-days following surgery
Title
Incidence of Adverse Events That Were Potentially Related to Thrombotic Events
Description
Number of participants with adverse events that were potentially related to thrombic events
Time Frame
Up to 60-days following surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Kocharian, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Investigation Site #13
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Clinical Investigation Site #10
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Clinical Investigation Site #16
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Clinical Investigation Site #12
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Clinical Investigation Site #15
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Clinical Investigation Site #9
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Investigation Site #11
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Clinical Investigation Site #14
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Clinical Investigation Site #8
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Investigation Site #17
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Clinical Investigation Site #3
City
Melbourne
ZIP/Postal Code
3004
Country
Australia
Facility Name
Clinical Investigation Site #2
City
Woodville South
ZIP/Postal Code
5011
Country
Australia
Facility Name
Clinical Investigation Site #1
City
Auckland
ZIP/Postal Code
93-503
Country
New Zealand
Facility Name
Clinical Investigation Site #6
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Clinical Investigation Site #7
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Clinical Investigation Site #4
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Clinical Investigation Site #5
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27017161
Citation
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.
Results Reference
result
PubMed Identifier
26636489
Citation
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.
Results Reference
derived

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The EVARREST® Fibrin Sealant Patch Liver Study

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