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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01993888
Registration number
NCT01993888
Ethics application status
Date submitted
19/11/2013
Date registered
25/11/2013
Date last updated
11/07/2016
Titles & IDs
Public title
The EVARREST® Fibrin Sealant Patch Liver Study
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Scientific title
A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery
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Secondary ID [1]
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2013-002535-24
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Secondary ID [2]
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BIOS-13-005
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hemorrhage
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - EVARREST® Fibrin Sealant Patch
Other interventions - Standard of Care (SoC)
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).
Other: Standard of Care (SoC) - 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. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
Other interventions: EVARREST® Fibrin Sealant Patch
Other interventions: Standard of Care (SoC)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
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Assessment method [1]
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Proportion of subjects achieving hemostasis at the TBS at 4-minutes following randomization and with no re-bleeding requiring treatment at the TBS any time prior to initiation of wound closure. Hemostasis is defined as no detectable bleeding at the TBS.
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Timepoint [1]
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Intraoperative, 4 minutes following randomization
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Secondary outcome [1]
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Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization
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Assessment method [1]
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Proportion of subjects achieving hemostatic success at 10 minutes following randomization and no further bleeding requiring treatment prior to initiation of wound closure.
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Timepoint [1]
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Intraoperative, 10 minutes following randomization
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Secondary outcome [2]
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Absolute Time to Hemostasis
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Assessment method [2]
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The absolute time to achieve hemostasis at or after 4 minutes from randomization.
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Timepoint [2]
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Intraoperative, an average of 4.2 minutes following randomization
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Secondary outcome [3]
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Incidence of Re-bleeding Events From the TBS During the Study Follow-up
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Assessment method [3]
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Timepoint [3]
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Up to 60-days following surgery
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Secondary outcome [4]
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Incidence of Adverse Events (AEs)
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Assessment method [4]
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Timepoint [4]
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Up to 60-days following surgery
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Secondary outcome [5]
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Incidence of Adverse Events That Were Potentially Related to Thrombotic Events
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Assessment method [5]
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Number of participants with adverse events that were potentially related to thrombic events
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Timepoint [5]
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Up to 60-days following surgery
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Eligibility
Key inclusion criteria
- Subjects = 18 years of age, requiring elective or urgent, open hepatic surgery.
- Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as
identified intra-operatively by the surgeon
- Subjects or legally authorized representatives must be willing to participate in the
study, and provide written informed consent. (Note: This criteria does allow for
hospital translators to be used where approved by Ethics Committees/Institutional
Review Boards)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects with any intra-operative findings identified by the surgeon that may preclude
conduct of the study procedure;
- TBS is from large defects in arteries or veins where the injured vascular wall
requires repair with maintenance of vessel patency and which would result in
persistent exposure of EVARREST® to blood flow and pressure during healing and
absorption of the product;
- TBS with major arterial bleeding requiring suture or mechanical ligation;
- Subjects admitted for trauma surgery;
- Subject is a transplant patient for fulminant hepatic failure
- Subject with 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 known intolerance to blood products or to one of the components of the
study product or is unwilling to receive blood products;
- Subjects who are known, current alcohol and / or drug abusers;
- Subjects who have participated in another investigational medical device or
investigational drug trial within 30 days of surgery or are expected to participate in
another medical device or investigational drug trial during the course of the study;
- Female subjects who are pregnant or nursing.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2014
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Sample size
Target
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Accrual to date
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Final
102
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Clinical Investigation Site #3 - Melbourne
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Recruitment hospital [2]
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Clinical Investigation Site #2 - Woodville South
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment postcode(s) [2]
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5011 - Woodville South
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Recruitment outside Australia
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United States of America
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Alabama
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Georgia
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United States of America
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Illinois
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United States of America
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Louisiana
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Missouri
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New York
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United States of America
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Pennsylvania
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New Zealand
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Auckland
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Edinburgh
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United Kingdom
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State/province [12]
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Leeds
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Ethicon, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch
(EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during
hepatic surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01993888
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Richard Kocharian, MD
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Address
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Ethicon, Inc.
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01993888
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