The EVARREST™ Fibrin Sealant Patch Liver Study

Hemorrhage Clinical Trial

Official title:

A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST™ Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993888
• Other study ID #: BIOS-13-005
• Secondary ID: 2013-002535-24
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2013
• Last updated: October 10, 2014
• Start date: October 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and hemostatic effectiveness of EVARREST™ Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects = 18 years of age, requiring elective or urgent, open hepatic surgery.

• Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon

• Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion Criteria:

• Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;

• TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST™ to blood flow and pressure during healing and absorption of the product;

• TBS with major arterial bleeding requiring suture or mechanical ligation;

• Subjects admitted for trauma surgery;

• Subject is a transplant patient for fulminant hepatic failure

• Subject with TBS within an actively infected field;

• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;

• Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;

• Subjects who are known, current alcohol and / or drug abusers;

• Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;

• Female subjects who are pregnant or nursing.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Biological:
• EVARREST™ Fibrin Sealant Patch

Other:
• Standard of Care (SoC)

Locations

Country	Name	City	State
Australia	Clinical Investigation Site #3	Melbourne
Australia	Clinical Investigation Site #2	Woodville South
New Zealand	Clinical Investigation Site #1	Auckland
United Kingdom	Clinical Investigation Site #6	Birmingham
United Kingdom	Clinical Investigation Site #7	Cambridge
United Kingdom	Clinical Investigation Site #4	Edinburgh
United Kingdom	Clinical Investigation Site #5	Leeds
United States	Clinical Investigation Site #10	Augusta	Georgia
United States	Clinical Investigation Site #13	Birmingham	Alabama
United States	Clinical Investigation Site #12	Chicago	Illinois
United States	Clinical Investigation Site #16	Chicago	Illinois
United States	Clinical Investigation Site #15	New Orleans	Louisiana
United States	Clinical Investigation Site #11	New York	New York
United States	Clinical Investigation Site #14	New York	New York
United States	Clinical Investigation Site #8	Philadelphia	Pennsylvania
United States	Clinical Investigation Site #17	Pittsburgh	Pennsylvania
United States	Clinical Investigation Site #9	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemostasis at the Target Bleeding Site (TBS) at 4-minutes following randomization	Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.	Intraoperative	Yes
Secondary	Hemostasis at the Target Bleeding Site (TBS) at 10-minutes following randomization	Proportion of subjects achieving hemostatic success at 10 minutes following randomization	Intraoperative	Yes
Secondary	Incidence of adverse events		up to 60-days	Yes
Secondary	Absolute time to hemostasis		Intraoperative	No