Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2013-003464-31
Query!
Secondary ID [2]
0
0
BIOS-13-004
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - EVARREST™ Fibrin Sealant Patch
Other interventions - Topical hemostat
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
Other interventions: EVARREST™ Fibrin Sealant Patch
Other interventions: Topical hemostat
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Query!
Assessment method [1]
0
0
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
Query!
Timepoint [1]
0
0
Intraoperative, 3 minutes following treatment application
Query!
Secondary outcome [1]
0
0
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Intraoperative, 6 minutes following treatment application
Query!
Secondary outcome [2]
0
0
Number of Participants With Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Intraoperative, 10 minutes following treatment application
Query!
Secondary outcome [3]
0
0
Number of Participants With Re-bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
Intra-operative, prior initiation of final chest wall closure.
Query!
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;
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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;
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/01/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
156
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Clinical Investigation Site #72 - Camperdown
Query!
Recruitment hospital [2]
0
0
Clinical Investigation Site #73 - Sydney
Query!
Recruitment hospital [3]
0
0
Clinical Investigation Site #71 - Brisbane
Query!
Recruitment hospital [4]
0
0
Clinical Investigation Site #74 - Bedford Park
Query!
Recruitment hospital [5]
0
0
Clinical Investigation Site #70 - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
4000 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [5]
0
0
3050 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Indiana
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maryland
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Missouri
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Pennsylvania
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Texas
Query!
Country [9]
0
0
Belgium
Query!
State/province [9]
0
0
Gent
Query!
Country [10]
0
0
Japan
Query!
State/province [10]
0
0
Isehara-shi
Query!
Country [11]
0
0
Japan
Query!
State/province [11]
0
0
Saitama-shi
Query!
Country [12]
0
0
Japan
Query!
State/province [12]
0
0
Suita-shi
Query!
Country [13]
0
0
United Kingdom
Query!
State/province [13]
0
0
England
Query!
Country [14]
0
0
United Kingdom
Query!
State/province [14]
0
0
Scotland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Ethicon, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02040428
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Richard Kocharian, MD, PhD
Query!
Address
0
0
Ethicon, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02040428
Download to PDF