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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Soft Tissue Bleeding
• Intervention / Treatment: Biological: EVARREST™ Fibrin Sealant Patch; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Clinical Site #10

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Surgery up until the 30 day follow-up
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.	Surgery up until the 30 day follow-up
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.	Surgery up until the 30 day follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.	This product is easy and quick to prepare for application to the target bleeding site.	Intraoperative
This Product is Easy to Apply to a Variety of Bleeding Sites.	This product is easy to apply to a variety of bleeding sites.	Intraoperative
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.	This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.	Intraoperative

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 15, 2013
• First Posted (Estimate): July 18, 2013

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 15, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Hemostasis
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hemostatics; Coagulants; Fibrin Tissue Adhesive
• Other Study ID Numbers: 400-12-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study endpoints

Drug and device information, study documents

• 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