Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

EVARREST™ Fibrin Sealant Patch Post-Market Study (EVARREST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01902459
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : January 17, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

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.

Condition or disease Intervention/treatment Phase
Hemorrhage Soft Tissue Bleeding Biological: EVARREST™ Fibrin Sealant Patch Other: Standard of Care Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : August 1, 2015
Actual Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: EVARREST™ Fibrin Sealant Patch
EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.
Biological: EVARREST™ Fibrin Sealant Patch
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.

Standard of Care
Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.
Other: Standard of Care
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 Measures :
  1. Safety Parameter - Incidence of Thromboembolic Events [ Time Frame: Surgery up until the 30 day follow-up ]
    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.

  2. Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS) [ Time Frame: Surgery up until the 30 day follow-up ]
    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.

  3. Safety Parameter - Incidence of Increase Blood Fibrinogen Level [ Time Frame: Surgery up until the 30 day follow-up ]
    Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.


Other Outcome Measures:
  1. This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. [ Time Frame: Intraoperative ]
    This product is easy and quick to prepare for application to the target bleeding site.

  2. This Product is Easy to Apply to a Variety of Bleeding Sites. [ Time Frame: Intraoperative ]
    This product is easy to apply to a variety of bleeding sites.

  3. This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. [ Time Frame: Intraoperative ]
    This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902459


Locations
Layout table for location information
United States, Missouri
Clinical Site #10
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Layout table for investigator information
Study Director: Richard Kocharian, MD Ethicon, Inc.

Layout table for additonal information
Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01902459     History of Changes
Other Study ID Numbers: 400-12-005
First Posted: July 18, 2013    Key Record Dates
Results First Posted: January 17, 2018
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study endpoints

Layout table for additional information
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

Keywords provided by Ethicon, Inc.:
Hemostasis

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Pathologic Processes
Hemostatics
Fibrin Tissue Adhesive
Coagulants