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Trial registered on ANZCTR


Registration number
ACTRN12616001698460
Ethics application status
Approved
Date submitted
7/12/2016
Date registered
9/12/2016
Date last updated
9/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Agreement and clinical interchangeability of a coagulation monitoring analyser between devices, operators, and across multiple time points.
Scientific title
Agreement and clinical interchangeability of the TEG6S (Registered) haemostatic analyser between devices, operators, and across multiple time points: a comprehensive prospective validation study
Secondary ID [1] 290704 0
Nil
Universal Trial Number (UTN)
U1111-1190-6485
Trial acronym
Non applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Coagulopathy 301260 0
Condition category
Condition code
Blood 301019 301019 0 0
Clotting disorders
Anaesthesiology 301020 301020 0 0
Other anaesthesiology
Surgery 301021 301021 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 study is an observational study to test “Interdevice” agreement", “Interoperator” agreement" and "time point agreement" using the TEG6S (Registered) device. No results results will be used by any clinician to influence patient care.

Skilled operators of the TEG6S (Registered) device 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 TEG6S (Registered) devices i.e. (“Interdevice” agreement).

Then, 5 different skilled operators will perform sample analyses from 5 healthy volunteers, perform measurements using 5 TEG6S (Registered) devices i.e. (“Interoperator” agreement).

Finally, a single operator will perform 15 measurements on 4 TEG6S (Registered) devices, with samples from 5 healthy volunteers, 5 surgical, and 5 ICU patients. Agreement across pre-set time points (0, 15, 60, 120 and 180 minutes) (“Timepoint” agreement) will be examined.

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] 296598 0
Not applicable
Comparator / control treatment
Comparing coagulation as assessed by multiple TEG6S devices and analysing the resulting difference in measurement in order to validate TEG6S device.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300441 0
Primary outcome 1: Interdevice agreement:
Global coagulation state of study subjects, as assessed by multiple TEG6S devices.
Timepoint [1] 300441 0
Duration of coagulation analysis = 60 minutes
Primary outcome [2] 300442 0
Primary outcome 2: Interoperator agreement:
Global coagulation state of study subjects, as assessed by multiple operators.
Timepoint [2] 300442 0
Duration of coagulation analysis = 60 minutes
Primary outcome [3] 300443 0
Primary outcome 3: Agreement across time-points:
Global coagulation state of study subjects, as assessed across multiple time-points since sampling.
Timepoint [3] 300443 0
Times points will 0, 15, 60, 120 and 180 minutes after sampling.
Secondary outcome [1] 329988 0
Interdevice agreement:
Coagulation initiation, denoted by TEG variable "clot reaction time", as assessed by multiple TEG6S devices.
Timepoint [1] 329988 0
0 - 15 minutes.

The TEG6S device examines different 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).

Coagulation initiation occurs between 0 - 15 minutes of analysis.
Secondary outcome [2] 329989 0
Interdevice agreement:
Coagulation speed, determined by clot kinetic time ("K time") and alpha angle, as assessed by multiple TEG6S devices.
Timepoint [2] 329989 0
0 - 20 minutes.

The TEG6S device examines different 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).

Coagulation speed is measured between 0 - 20 minutes of analysis.
Secondary outcome [3] 329990 0
Interdevice agreement:
Thrombus strength, determined by clot maximal amplitude, as assessed by multiple TEG6S devices.
Timepoint [3] 329990 0
0 - 30 minutes.

The TEG6S device examines different 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).

Thrombus strength is measured between 0 - 30 minutes of analysis.
Secondary outcome [4] 329991 0
Interdevice agreement:
Rate/degree of fibrinolysis, determined by clot lysis percentage, as assessed by multiple TEG6S devices.
Timepoint [4] 329991 0
0 - 60 minutes.

The TEG6S device examines different 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).

The measurement of the rate and degree of fibrinolysis occurs between 0 - 60 minutes of analysis.
Secondary outcome [5] 329992 0
Interoperator agreement:
Coagulation initiation, denoted by TEG variable "clot reaction time", as assessed by multiple operators using the same TEG6S device.
Timepoint [5] 329992 0
0 - 15 minutes.

The TEG6S device examines different 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).

Coagulation initiation occurs between 0 - 15 minutes of analysis.
Secondary outcome [6] 329993 0
Interoperator agreement:
Coagulation speed, determined by clot kinetic time ("K time") and alpha angle, as assessed by multiple operators using the same TEG6S device.
Timepoint [6] 329993 0
0 - 20 minutes.

The TEG6S device examines different 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).

Coagulation speed is measured between 0 - 20 minutes of analysis.
Secondary outcome [7] 329994 0
Interoperator agreement:
Thrombus strength, determined by clot maximal amplitude, as assessed by multiple operators using the same TEG6S device.
Timepoint [7] 329994 0
0 - 30 minutes.

The TEG6S device examines different 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).

Thrombus strength is measured between 0 - 30 minutes of analysis.
Secondary outcome [8] 329995 0
Interoperator agreement:
Rate/degree of fibrinolysis, determined by clot lysis percentage, as assessed by multiple operators using the same TEG6S device.
Timepoint [8] 329995 0
0 - 60 minutes.

The TEG6S device examines different 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).

The measurement of the rate and degree of fibrinolysis occurs between 0 - 60 minutes of analysis.
Secondary outcome [9] 329996 0
Agreement across time-points:
Coagulation initiation, denoted by TEG variable "clot reaction time", as assessed across multiple time-points from the moment the sample was collected.
Timepoint [9] 329996 0
Samples analysed at: 0, 15, 60, 120 and 180 minutes after sampling from the subjects.
After analysis by TEG6S is initiated, coagulation initiation occurs between 0 - 15 minutes.
Secondary outcome [10] 329997 0
Agreement across time-points:
Coagulation speed, determined by clot kinetic time ("K time") and alpha angle, as assessed across multiple time-points from the moment the sample was collected from each subject.
Timepoint [10] 329997 0
Samples analysed at: 0, 15, 60, 120 and 180 minutes after sampling from the subjects.
Coagulation speed is measured between 0 - 20 minutes of analysis.
Secondary outcome [11] 329998 0
Agreement across time-points:
Thrombus strength, determined by clot maximal amplitude, as assessed across multiple time-points from the moment the sample was collected from each subject.
Timepoint [11] 329998 0
Samples analysed at: 0, 15, 60, 120 and 180 minutes after sampling from the subjects.
Thrombus strength is measured between 0 - 30 minutes of analysis.
Secondary outcome [12] 329999 0
Agreement across time-points:
Rate/degree of fibrinolysis, determined by clot lysis percentage, as assessed across multiple time-points from the moment the sample was collected from each subject.
Timepoint [12] 329999 0
Samples analysed at: 0, 15, 60, 120 and 180 minutes after sampling from the subjects.
The measurement of the rate and degree of fibrinolysis occurs between 0 - 60 minutes of analysis.

Eligibility
Key inclusion criteria
1. Patients admitted to ICU who required an arterial line as part of standard care.
2. Patients admitted to ICU who receive TEG as part of standard routine hospital care.
3. Patients undergoing major cardiac surgery who receive TEG as part of standard routine hospital care.
4. Age >18 years.
5. Healthy volunteers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects who were less than 18 years old.
2. Subjects who would not otherwise require TEG assessment as part of their standard clinical care.
3. Healthy volunteers with any chronic medical condition or complex comorbidity
4. Healthy volunteers on any regular medication, including the oral contraceptive pill

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. Values of 1 denote perfect concordance; a value of zero denotes its complete absence. “Interoperator” and “Timepoint” agreement was assessed using the Intraclass correlation coefficient estimated by a random effect regression model. Intraclass correlation is the assessment of consistency or reproducibility of quantitative measurements, made by different operators or across different time points using the same device. 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
9/04/2015
Date of last participant enrolment
Anticipated
Actual
12/09/2015
Date of last data collection
Anticipated
Actual
12/09/2015
Sample size
Target
33
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7088 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 14817 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 295134 0
Hospital
Name [1] 295134 0
Austin Hospital Anaesthesia and Intensive Care Research Fund
Country [1] 295134 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
145 Studley Rd
Heidelberg
VIC
3084
Country
Australia
Secondary sponsor category [1] 293956 0
None
Name [1] 293956 0
Address [1] 293956 0
Country [1] 293956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296483 0
Austin Health Research and Ethics Committee
Ethics committee address [1] 296483 0
Research Ethics
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 296483 0
Australia
Date submitted for ethics approval [1] 296483 0
25/08/2014
Approval date [1] 296483 0
01/12/2014
Ethics approval number [1] 296483 0
LNR/14/Austin/435

Summary
Brief summary
TEG6S (Haemonetics Corp, USA) is a novel haemostasis analyser that measures viscoelasticity properties of blood using resonance technology. We assessed agreement of the TEG6S analyser between devices, operators, and across multiple time points.

We collected 3.5mL whole blood in citrated tubes from 25 adult patients in a tertiary level intensive care unit (ICU). Measurements were performed by one operator on two TEG6S devices (“Interdevice” agreement). Then, 5 different operators performed sample analysis from 5 healthy volunteers, using 5 TEG6S devices (“Interoperator” agreement). Finally, a single operator performed 15 measurements on 4 TEG6S devices, with samples from 5 healthy volunteers, 5 surgical, and 5 ICU patients. Agreement across pre-set time points (0, 15, 60, 120 and 180 minutes) (“Timepoint” agreement) was examined. “Interdevice” agreement was estimated using Lin’s condordance coefficient and further validated using intraclass correlation coefficients and reduced major axis regression. “Interoperator” and “Timepoint” agreement was assessed using the Intraclass correlation coefficient estimated by a random effect regression model.
Trial website
Nil
Trial related presentations / publications
Lloyd-Donald P, Zia F, Bellomo R, Hart G, Churilov L, Weinberg L.
Agreement and clinical interchangeability of the TEG6S haemostat analyser between devices, operators, and across multiple time points: a comprehensive prospective validation study. European Journal of Anaesthesiology 33(eSupplement 54):11AP11-2. June 2016
Public notes

Contacts
Principal investigator
Name 70622 0
A/Prof Laurence Weinberg
Address 70622 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 70622 0
Australia
Phone 70622 0
+ 61394965000
Fax 70622 0
+ 61394596421
Email 70622 0
[email protected]
Contact person for public queries
Name 70623 0
Laurence Weinberg
Address 70623 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 70623 0
Australia
Phone 70623 0
+ 61394965000
Fax 70623 0
+ 61394596421
Email 70623 0
[email protected]
Contact person for scientific queries
Name 70624 0
Laurence Weinberg
Address 70624 0
Department of Anaesthesia, Austin Hospital
152 Studley Road, Heidelberg, 3084, Victoria
Country 70624 0
Australia
Phone 70624 0
+ 61394965000
Fax 70624 0
+ 61394596421
Email 70624 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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