The Fibrin Pad Cardiovascular Study

Cardiovascular Disease Clinical Trial

Official title:

A Randomized, Controlled, Comparative Phase II 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: NCT01681030
• Other study ID #: 400-12-002
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2012
• Est. completion date: September 3, 2013

Study information

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

Clinical Trial Summary

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 3, 2013
• Est. primary completion date: August 1, 2013
• 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 must be willing to participate in the study and provide written informed consent.

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 30 day follow up period after surgery.

• Female subjects who are pregnant or nursing.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Biological:
• EVARREST™
EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts— a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
• Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin

Other:
• Standard of Care
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.

Locations

Country	Name	City	State
United States	Clinical Investigation Site #4	Camden	New Jersey
United States	Clinical Investigation Site #5	Indianapolis	Indiana
United States	Clinical Investigation Site #6	Kansas City	Missouri
United States	Clinical Investigation Site #2	New York	New York
United States	Clinical Investigation Site #3	New York	New York
United States	Clinical Investigation Site #1	Paterson	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 closur	Intraoperative, 3 minutes following treatment application
Secondary	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.	Intraoperative, 6 minutes following treatment application
Secondary	Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application	Number of subjects achieving hemostatic success at 10 minutes following treatment application.	Intraoperative, 10 minutes following treatment application
Secondary	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 re-bleeding requiring treatment	Intra-operative, prior initiation of final chest wall closure. Safety Issue:
Secondary	Number of Participants With Adverse Events Potentially Related to Thrombotic Events	The number of subjects with an adverse event potentially related to a thrombotic event	30 days (+ 14 days) following surgery