Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000187246
Ethics application status
Approved
Date submitted
24/02/2009
Date registered
17/04/2009
Date last updated
17/04/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Influence of Venous Tourniquet on Whole Blood Coagulation as Assessed by Thrombelastography (TEG)
Scientific title
Measuring the effect of using a venous tourniquet for blood sampling on whole blood coagulation as assessed by thromboelastography in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disorders of coagulation 4379 0
Condition category
Condition code
Blood 4625 4625 0 0
Clotting disorders
Anaesthesiology 4626 4626 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single blood sample is taken from the antecubital fossa without the use of a venous tourniquet, using a 18g needle and 5 ml syringe. After a 5 minute period a second venous blood sample taken from the contralateral antecubital fossa. A venous tourniquet is use on this occasion for blood sampling. The tourniquet is applied for 30 seconds at 45mmHg prior venous puncture and released immediately after.This is also single venous puncture using a 18g needle and 5 ml syringe. This therefore forms a crossover study.
Intervention code [1] 4111 0
Diagnosis / Prognosis
Comparator / control treatment
Collection of blood sample without a venous tourniquet as explained above.
Control group
Active

Outcomes
Primary outcome [1] 5495 0
Maximum clot strength as assessed by the thromboelastography (TEG) variable 'Maximum amplitude'
Timepoint [1] 5495 0
The Maximum amplitude (TEG value) time point is variable between patients and is not fixed.
Primary outcome [2] 5496 0
Fibrinolysis, as assessed by thromboelastography and identified by the Lysis 30 and Lysis 60 variables.
Timepoint [2] 5496 0
The Lysis 30 and Lysis 60 (TEG values) time points are variable between patients and are not therefore fixed.
Secondary outcome [1] 9257 0
Initiation of clotting as assessed by thromboelastography and identified by the Reaction - time (R-time) variable.
Timepoint [1] 9257 0
The Reaction - time (R-time) time point is variable between patients and is not therefore fixed.

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prescription of any antiplatelet medication
2. Confirmed coagulation disorder (pathological or drug induced)
3. Confirmed systemic Inflammatory diseases
4. known pregnancy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Crossover
Other design features
Pilot quality control study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/02/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4554 0
Self funded/Unfunded
Name [1] 4554 0
Department of Anaesthesia
Country [1] 4554 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Country
Australia
Secondary sponsor category [1] 4110 0
None
Name [1] 4110 0
Address [1] 4110 0
Country [1] 4110 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6604 0
Royal Perth Ethics Committee
Ethics committee address [1] 6604 0
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Ethics committee country [1] 6604 0
Australia
Date submitted for ethics approval [1] 6604 0
Approval date [1] 6604 0
Ethics approval number [1] 6604 0

Summary
Brief summary
Thromboelastography (TEG) is an in vitro method of measuring whole blood coagulation. It is, however, unknown whether the use of a venous tourniquet during blood sampling effects the results, making interpretation of a patients coagulation unreliable. This trial aims to answer this question.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29320 0
Address 29320 0
Country 29320 0
Phone 29320 0
Fax 29320 0
Email 29320 0
Contact person for public queries
Name 12567 0
Dr Thomas Collyer
Address 12567 0
Department of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Country 12567 0
Australia
Phone 12567 0
+61 (0)424661181
Fax 12567 0
Email 12567 0
[email protected]
Contact person for scientific queries
Name 3495 0
Dr Thomas Collyer
Address 3495 0
Department of Anaesthesia
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Country 3495 0
Australia
Phone 3495 0
+61 (0)424661181
Fax 3495 0
Email 3495 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.