EVARREST™ Fibrin Sealant Patch Post-Market Study

Hemorrhage Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902459
• Other study ID #: 400-12-005
• Status: Completed
• Phase: Phase 4
• First received: July 15, 2013
• Last updated: January 15, 2018
• Start date: July 1, 2013
• Est. completion date: September 1, 2015

Study information

• Verified date: January 2018
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 1, 2015
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Hemorrhage
• Soft Tissue Bleeding

Intervention

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 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.

Locations

Country	Name	City	State
United States	Clinical Site #10	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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