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Trial registered on ANZCTR


Registration number
ACTRN12617000062325
Ethics application status
Approved
Date submitted
8/01/2017
Date registered
12/01/2017
Date last updated
12/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Agreement between TEG6S(Registered) and TEG5000(Registered) devices
Scientific title
Assessment of agreement and clinical interchangeability between the TEG5000(Registered) and TEG6S(Registered) thromboelastography haemostasis analysers: a prospective validation study
Secondary ID [1] 289179 0
None
Universal Trial Number (UTN)
U1111-1182-7814
Trial acronym
Not applicable
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Coagulation 298722 0
Surgery 298725 0
Anaesthesia 298726 0
Intensive Care Medicine 298727 0
Condition category
Condition code
Blood 298775 298775 0 0
Clotting disorders
Anaesthesiology 298776 298776 0 0
Other anaesthesiology
Surgery 298777 298777 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observation study. No results will be used by any clinician to influence patient care.

TEG6s (Registered) and TEG5000 (Registered) (Haemonetics Corp, USA) are commercial haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess identical coagulation variables. The aim of this observational study was to assess agreement and clinical interchangeability between the TEG6s and TEG5000 analysers.

A trained operator, proficient in the use of both the TEG6s and TEG5000 systems will perform all the measurements. The skilled operator will collect 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit. Measurements will be performed by one operator on two TEG devices i.e. (“Interdevice” agreement). Five variables will be examined on each device. Agreement between these variables will be compared.
The variables to measured include:
1. Reaction Time (R) measured in minutes
2. Kinetics Time (K) measured in minutes
3. Alpha Angle (AA) measured in degrees
4. Maximum Amplitude (MA), measured in millimetres
5. Lysis 30 (LY30), measured as a percentage (%)

Duration of follow up will be until each test has been completed. This takes approximately 60 minutes. There is no patient follow up as this study is device validation study.
Intervention code [1] 296471 0
Not applicable
Comparator / control treatment
Comparing coagulation as assessed by the newer TEG6S global coagulation assessment device with the existing TEG5000 device.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300434 0
Primary outcome assessed: Agreement the TEG6S and TEG5000 devices in measuring global coagulation in subjects.

Both the TEG6S and TEG5000 devices examine the same components of the coagulation process, assessing blood as it clots in real time. This provides an overview of the function of various components of the coagulation process (such as coagulation initiation, coagulation rate, thrombus strength and the rate and degree of fibrinolysis), as well as providing an indication of overall coagulation state, that is, whether a subject is broadly hypo-, hyper- or normocoagulative.
Timepoint [1] 300434 0
Duration of thisTEG measurement will be over a 60 minute period.
Secondary outcome [1] 329976 0
Agreement between the TEG6S and TEG5000 devices in measuring the Reaction Time (R), measured in minutes.
Timepoint [1] 329976 0
Duration of this TEG measurement will be over a 60 minute period.
Secondary outcome [2] 329977 0
Agreement between the TEG6S and TEG5000 devices in measuring the clot kinetic time (K time), measured in minutes.
Timepoint [2] 329977 0
Duration of this TEG measurement will be over a 60 minute period.
Secondary outcome [3] 329978 0
Agreement between the TEG6S and TEG5000 devices in measuring the Alpha Angle (AA,) measured in degrees.
Timepoint [3] 329978 0
Duration of this TEG measurement will be over a 60 minute period.
Secondary outcome [4] 329979 0
Agreement between the TEG6S and TEG5000 devices in measuring the Maximum Amplitude (MA), measured in millimetres.
Timepoint [4] 329979 0
Duration of thisTEG measurement will be over a 60 minute period.
Secondary outcome [5] 330695 0
Agreement between the TEG6S and TEG5000 devices in measuring the Lysis 30 (LY30), measured as a percentage.
Timepoint [5] 330695 0
Duration of thisTEG measurement will be over a 60 minute period.

Eligibility
Key inclusion criteria
Patients admitted to ICU who required an arterial line as part of standard care.
Patients admitted to ICU who receive TEG as part of standard routine hospital care.
Patients undergoing major cardiac surgery who receive TEG as part of standard routine hospital care.
Adult patients (Age 18 years or greater)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects less than 18 years old.
Subjects who would not otherwise require TEG assessment as part of their standard clinical care.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Statistical analysis was performed using commercial statistical software STATA/IC v.13 with a p value of 0.05 to indicate statistical significance. “Interdevice” agreement was estimated using Lin’s condordance coefficient and further validated using intraclass correlation coefficients and reduced major axis regression. Lin’s concordance assesses the degree of agreement between two continuous variables and calculates the value of Lin’s concordance correlation coefficient. A value of 1 denotes perfect concordance; a value of zero denotes its complete absence. Due to the pragmatic and exploratory nature of the study, power calculations were not performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7083 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 14811 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295132 0
Hospital
Name [1] 295132 0
Austin Hospital Anaesthesia and Intensive Care Research Fund
Address [1] 295132 0
Austin Hospital
145 Studley Rd
Heidelberg
VIC
3084
Country [1] 295132 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
145 Studley Road, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 293955 0
None
Name [1] 293955 0
Address [1] 293955 0
Country [1] 293955 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296482 0
Austin Health Research and Ethics Committee
Ethics committee address [1] 296482 0
Research Ethics
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 296482 0
Australia
Date submitted for ethics approval [1] 296482 0
30/10/2014
Approval date [1] 296482 0
20/11/2014
Ethics approval number [1] 296482 0
Approval number: 05006/2013

Summary
Brief summary
Thromboelastography (TEG) allows rapid, comprehensive and accurate identification of an individual’s haemostasis condition in a laboratory or point-of-care setting. Until now, different TEG assays had to be performed individually, with each assay requiring lengthy preparation and calibrated pipetting. TEG6s and TEG5000 (Haemonetics Corp, USA) are commercial haemostasis analysers that measure viscoelasticity properties of whole blood. Both use different mechanisms to assess identical coagulation variables. The aim of this study was to assess agreement and clinical interchangeability between the TEG6s and TEG5000 analysers.

After Ethics Committee approval, we systematically collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). A trained operator, proficient in the use of both the TEG6S and TEG5000 systems performed all the measurements. Interdevice agreement between the TEG6S and TEG5000 analysers was measured using Lin’s condordance coefficient, and further validated this using intraclass correlation coefficients and reduced major axis regression, which allowed separation of the observed bias into fixed and proportional components.

As this is an observational device study, no results results will be used by any clinician to influence patient care.
Trial website
Not applicable
Trial related presentations / publications
Lloyd-Donald P, Zia F, Bellomo R, Hart G, Churilov L, Weinberg L. Assessment of agreement and clinical interchangeability between the TEG5000 and TEG6S thromboelastography haemostasis analysers: a prospective validation study. European Journal of Anaesthesiology 33(Supplement 54):11AP04-13. June 2016.
Public notes

Contacts
Principal investigator
Name 65754 0
A/Prof Laurence Weinberg
Address 65754 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 65754 0
Australia
Phone 65754 0
+ 61394965000
Fax 65754 0
Email 65754 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 65755 0
A/Prof Laurence Weinberg
Address 65755 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 65755 0
Australia
Phone 65755 0
+ 61394965000
Fax 65755 0
Email 65755 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 65756 0
A/Prof Laurence Weinberg
Address 65756 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 65756 0
Australia
Phone 65756 0
+ 61394965000
Fax 65756 0
Email 65756 0
laurence.weinberg@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary