Back to resultsEVARREST™ Fibrin Sealant Patch Post-Market Study (EVARREST)
Primary Purpose
Hemorrhage, Soft Tissue Bleeding
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
EVARREST™ Fibrin Sealant Patch
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring Hemostasis
Eligibility Criteria
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;
Sites / Locations
- Clinical Site #10
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
EVARREST™ Fibrin Sealant Patch
Standard of Care
Arm Description
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.
Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.
Outcomes
Primary Outcome Measures
Safety Parameter - Incidence of Thromboembolic Events
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)
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
Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01902459
Brief Title
EVARREST™ Fibrin Sealant Patch Post-Market Study
Acronym
EVARREST
Official Title
A Non-Investigational Post-Market Trial Using EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis in Soft Tissue Bleeding During Intra-Abdominal, Retroperitoneal, Pelvic and Non-Cardiac Thoracic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
August 1, 2015 (Actual)
Study Completion Date
September 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Soft Tissue Bleeding
Keywords
Hemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVARREST™ Fibrin Sealant Patch
Arm Type
Active Comparator
Arm Description
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.
Intervention Type
Biological
Intervention Name(s)
EVARREST™ Fibrin Sealant Patch
Intervention Description
EVARREST™ Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Parameter - Incidence of Thromboembolic Events
Description
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.
Time Frame
Surgery up until the 30 day follow-up
Title
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
Description
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.
Time Frame
Surgery up until the 30 day follow-up
Title
Safety Parameter - Incidence of Increase Blood Fibrinogen Level
Description
Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.
Time Frame
Surgery up until the 30 day follow-up
Other Pre-specified Outcome Measures:
Title
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
Description
This product is easy and quick to prepare for application to the target bleeding site.
Time Frame
Intraoperative
Title
This Product is Easy to Apply to a Variety of Bleeding Sites.
Description
This product is easy to apply to a variety of bleeding sites.
Time Frame
Intraoperative
Title
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
Description
This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.
Time Frame
Intraoperative
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 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;
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 Site #10
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study endpoints
Learn more about this trial
EVARREST™ Fibrin Sealant Patch Post-Market Study
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