EVARREST™ Fibrin Sealant Patch Post-Market Study

NCT01902459 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 400-12-005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Soft Tissue Bleeding

Keywords

Hemostasis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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.

  Intraoperative

• This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.

  Intraoperative

Study Arms (2)

EVARREST™ Fibrin Sealant Patch

ACTIVE COMPARATOR

EVARREST™ Fibrin Sealant Patch consists of human fibrinogen and human thrombin embedded in a flexible composite patch component.

Biological: EVARREST™ Fibrin Sealant Patch

Standard of Care

OTHER

Standard of Care (SoC) is manual compression with or without a topical absorbable hemostat.

Other: Standard of Care

Interventions

EVARREST™ Fibrin Sealant Patch BIOLOGICAL

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.

EVARREST™ Fibrin Sealant Patch

Standard of Care OTHER

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.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (1)

Clinical Site #10

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.

  PMID: 38695613 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Richard Kocharian, MD, PhD
• Organization: Ethicon, Inc

rkochar1@its.jnj.com

+1 908-218-2013

Study Officials

• Richard Kocharian, MD

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 17, 2018
• Results First Posted: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)