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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02040428




Registration number
NCT02040428
Ethics application status
Date submitted
17/01/2014
Date registered
20/01/2014
Date last updated
15/08/2017

Titles & IDs
Public title
The Fibrin Pad CV Phase III Study
Scientific 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
Secondary ID [1] 0 0
2013-003464-31
Secondary ID [2] 0 0
BIOS-13-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: EVARREST™ Fibrin Sealant Patch - 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).

Active comparator: Topical hemostat - Equine collagen with Human Fibrinogen and Human Thrombin
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Timepoint [1] 0 0
Intraoperative, 3 minutes following treatment application
Secondary outcome [1] 0 0
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
Timepoint [1] 0 0
Intraoperative, 6 minutes following treatment application
Secondary outcome [2] 0 0
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Timepoint [2] 0 0
Intraoperative, 10 minutes following treatment application
Secondary outcome [3] 0 0
Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
Timepoint [3] 0 0
Intra-operative, prior initiation of final chest wall closure.

Eligibility
Key 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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Clinical Investigation Site #72 - Camperdown
Recruitment hospital [2] 0 0
Clinical Investigation Site #73 - Sydney
Recruitment hospital [3] 0 0
Clinical Investigation Site #71 - Brisbane
Recruitment hospital [4] 0 0
Clinical Investigation Site #74 - Bedford Park
Recruitment hospital [5] 0 0
Clinical Investigation Site #70 - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4000 - Brisbane
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Japan
State/province [10] 0 0
Isehara-shi
Country [11] 0 0
Japan
State/province [11] 0 0
Saitama-shi
Country [12] 0 0
Japan
State/province [12] 0 0
Suita-shi
Country [13] 0 0
United Kingdom
State/province [13] 0 0
England
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Scotland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ethicon, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02040428
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard Kocharian, MD, PhD
Address 0 0
Ethicon, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02040428