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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02040428