Clinical trial NCT02040428: The Fibrin Pad CV Phase III Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease
Keywords: Cardiovascular Diseases
Fibrin Sealant
Hemostatics
Coagulants
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
timeFrame: Intraoperative, 3 minutes following treatment application
Secondary outcomes:
measure: Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
timeFrame: Intraoperative, 6 minutes following treatment application
measure: Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
timeFrame: Intraoperative, 10 minutes following treatment application
measure: Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
timeFrame: Intra-operative, prior initiation of final chest wall closure.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Clinical Investigation Site #15
state: Georgia
city: Indianapolis
country: United States
facility: Clinical Investigation Site #14
state: Indiana
city: Baltimore
country: United States
facility: Clinical Investigation Site #16
state: Maryland
city: Bethesda
country: United States
facility: Clinical Investigation Site #21
state: Maryland
city: Saint Louis
country: United States
facility: Clinical Investigation Site #17
state: Missouri
city: Paterson
country: United States
facility: Clinical Investigation Site #10
state: New Jersey
city: New York
country: United States
facility: Clinical Investigation Site #12
state: New York
city: Philadelphia
country: United States
facility: Clinical Investigation Site #20
state: Pennsylvania
city: Houston
country: United States
facility: Clinical Investigation Site #18
state: Texas
city: Camperdown
country: Australia
facility: Clinical Investigation Site #72
state: New South Wales
city: Sydney
country: Australia
facility: Clinical Investigation Site #73
state: New South Wales
city: Brisbane
country: Australia
facility: Clinical Investigation Site #71
state: Queensland
city: Bedford Park
country: Australia
facility: Clinical Investigation Site #74
state: South Australia
city: Melbourne
country: Australia
facility: Clinical Investigation Site #70
state: Victoria
city: Gent
country: Belgium
facility: Clinical Investigation Site #40
city: Kanagawa
country: Japan
facility: Clinical Investigation Site #82
state: Isehara-shi
city: Saitama
country: Japan
facility: Clinical Investigation Site #81
state: Saitama-shi
city: Osaka
country: Japan
facility: Clinical Investigation Site #80
state: Suita-shi
city: Bristol
country: United Kingdom
facility: Clinical Investigation Site #33
state: England
city: Cottingham
country: United Kingdom
facility: Clinical Investigation Site #35
state: England
city: Manchester
country: United Kingdom
facility: Clinical Investigation Site #34
state: England
city: Aberdeen
country: United Kingdom
facility: Clinical Investigation Site #32
state: Scotland
city: Clydebank
country: United Kingdom
facility: Clinical Investigation Site #31
state: Scotland
city: Edinburgh
country: United Kingdom
facility: Clinical Investigation Site #30
state: Scotland
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD, PhD
role: STUDY_DIRECTOR
References: