The Fibrin Pad CV Phase III Study

Cardiovascular Disease Clinical Trial

Official title:

A Single-blinded, Randomized, Controlled, Comparative Phase III Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040428
• Other study ID #: BIOS-13-004
• Secondary ID: 2013-003464-31
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2014
• Last updated: August 14, 2017
• Start date: January 1, 2014
• Est. completion date: September 1, 2015

Study information

• Verified date: August 2017
• 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 safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 1, 2015
• Est. primary completion date: July 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 aortic surgical procedure utilizing cardiopulmonary bypass. Subjects in Japan between =18 and <20 years of age will require consent by the subject's legal representative

• Subjects must be willing to participate in the study and provide written informed consent.

• Presence of an appropriate Target Bleeding Site (TBS) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator;

Exclusion Criteria:

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

• Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery.

• Female subjects who are pregnant or nursing.

• TBS is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ Fibrin Sealant Patch to blood flow and/or pressure during absorption of the product;

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

• TBS involves an expanded polytetrafluoroethylene (ePTFE) graft

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Biological:
• EVARREST™ Fibrin Sealant Patch

• Topical hemostat

Locations

Country	Name	City	State
Australia	Clinical Investigation Site #74	Bedford Park	South Australia
Australia	Clinical Investigation Site #71	Brisbane	Queensland
Australia	Clinical Investigation Site #72	Camperdown	New South Wales
Australia	Clinical Investigation Site #70	Melbourne	Victoria
Australia	Clinical Investigation Site #73	Sydney	New South Wales
Belgium	Clinical Investigation Site #40	Gent
Japan	Clinical Investigation Site #82	Kanagawa	Isehara-shi
Japan	Clinical Investigation Site #80	Osaka	Suita-shi
Japan	Clinical Investigation Site #81	Saitama	Saitama-shi
United Kingdom	Clinical Investigation Site #32	Aberdeen	Scotland
United Kingdom	Clinical Investigation Site #33	Bristol	England
United Kingdom	Clinical Investigation Site #31	Clydebank	Scotland
United Kingdom	Clinical Investigation Site #35	Cottingham	England
United Kingdom	Clinical Investigation Site #30	Edinburgh	Scotland
United Kingdom	Clinical Investigation Site #34	Manchester	England
United States	Clinical Investigation Site #15	Atlanta	Georgia
United States	Clinical Investigation Site #16	Baltimore	Maryland
United States	Clinical Investigation Site #21	Bethesda	Maryland
United States	Clinical Investigation Site #18	Houston	Texas
United States	Clinical Investigation Site #14	Indianapolis	Indiana
United States	Clinical Investigation Site #12	New York	New York
United States	Clinical Investigation Site #10	Paterson	New Jersey
United States	Clinical Investigation Site #20	Philadelphia	Pennsylvania
United States	Clinical Investigation Site #17	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Japan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.	Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure	Intraoperative, 3 minutes following treatment application
Secondary	Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application	The number of subjects achieving hemostatic success at 6 minutes following treatment application with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.	Intraoperative, 6 minutes following treatment application
Secondary	Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application	The number of subjects achieving hemostatic success at 10 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closure.	Intraoperative, 10 minutes following treatment application
Secondary	Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment	The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had intra-operative re-bleeding requiring treatment at the TBS	Intra-operative, prior initiation of final chest wall closure.