Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2013-002535-24
Secondary ID [2] 0 0
BIOS-13-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemorrhage 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).

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).
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Hemostasis at the Target Bleeding Site (TBS) at 4-minutes Following Randomization
Timepoint [1] 0 0
Intraoperative, 4 minutes following randomization
Secondary outcome [1] 0 0
Hemostasis at the Target Bleeding Site (TBS) at 10-minutes Following Randomization
Timepoint [1] 0 0
Intraoperative, 10 minutes following randomization
Secondary outcome [2] 0 0
Absolute Time to Hemostasis
Timepoint [2] 0 0
Intraoperative, an average of 4.2 minutes following randomization
Secondary outcome [3] 0 0
Incidence of Re-bleeding Events From the TBS During the Study Follow-up
Timepoint [3] 0 0
Up to 60-days following surgery
Secondary outcome [4] 0 0
Incidence of Adverse Events (AEs)
Timepoint [4] 0 0
Up to 60-days following surgery
Secondary outcome [5] 0 0
Incidence of Adverse Events That Were Potentially Related to Thrombotic Events
Timepoint [5] 0 0
Up to 60-days following surgery

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Open (masking not used)
Who is / are masked / blinded?



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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Clinical Investigation Site #3 - Melbourne
Recruitment hospital [2] 0 0
Clinical Investigation Site #2 - Woodville South
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
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
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Birmingham
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Cambridge
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Edinburgh
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Leeds

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
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Koea JB, Batiller J, Aguirre N, Shen J, Kocharian ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01993888