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Trial registered on ANZCTR
Registration number
ACTRN12612000867897
Ethics application status
Approved
Date submitted
13/08/2012
Date registered
16/08/2012
Date last updated
16/08/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Obtaining thrombelastography (TEG) measurements for healthy pregnant mothers and applying the results to help manage major bleeding following birth.
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Scientific title
In healthy women at term (gestation > 37 weeks), how do reference values for activated (kaolin and RapidTEG(Registered Trademark)) thromboelastogram parameters compare with reference values using a non-activated (native) assay and how these reference values can determine reference intervals.
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Secondary ID [1]
281012
0
Nil
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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:
Reproductive Health and Childbirth
287146
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Blood Clotting
287172
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Condition category
Condition code
Blood
287467
287467
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0
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Clotting disorders
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Reproductive Health and Childbirth
287501
287501
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0
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Normal pregnancy
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
All participants provided a single venous specimen which underwent simultaneous analyses using three different assays; Native, Kaolin-activated and RapidTEG-activated.
A specimen was obtained immediately prior to caesarean. Specimens were analysed using a dedicated TEG(registered Trademark) device. Processing is undertaken at the point-of-collection on 3 available channels.
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Intervention code [1]
285471
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Not applicable
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Comparator / control treatment
Native
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Control group
Active
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Outcomes
Primary outcome [1]
287735
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Reference VALUES for four thromboelastography parameters (r-time, k-time, alpha-angle and maximum amplitude)
The collection and processing of blood occurred in the following order. Following intravenous access, an initial 2ml of blood was drawn into a plain syringe that was discarded to ensure any potential contamination during drawing was removed. A second sample of 4ml of blood was drawn into a second plain syringe which was used for TEG(Registered Trademark) testing. A stopwatch was used to ensure samples were processed as per the manufacturers recommended time of 4 minutes. One ml of whole blood was placed into a Kaolin vial and gently
inverted five times with the remainder of the whole blood sample from the plain syringe being placed in a plain plastic test tube. For the Kaolin test, 360 microlitres of blood was pipetted from the mixed Kaolin vial, into a plain TEG(Registered Trademark) cup and testing commenced. For the RapidTEG(Registered Trademark)test, 10 microlitres of RapidTEG(Registered Trademark) reagent comprising of lyophilized Kaolin & Tissue Factor (which had been reconstituted with 20 microlitres of sterile water, 5 minutes prior to the testing) was placed in a plain TEG(Registered Trademark) cup, followed by 360 microlitres of blood pipetted from the plastic test tube and testing commenced. For the Native test, 360 microlitres of blood from the plastic test tube was transferred into a plain TEG(Registered Trademark) cup, and testing commenced 4 minutes after the initial drawing of blood Real-time results are presented on a networked monitor using TEG(Registered Trademark)AnalyticalSoftwareV4.2.97.
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Assessment method [1]
287735
0
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Timepoint [1]
287735
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Timepoint: Point-of-care analyses ensure immediate processing
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Primary outcome [2]
287736
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Reference INTERVALS for four thromboelastography parameters (r-time, k-time, alpha-angle and maximum amplitude)
Electronically store reference values are exported to be analysed using MedCalc (Registered Trademark) software.
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Assessment method [2]
287736
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Timepoint [2]
287736
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Timepoint: determined following the analyses of all venous-blood specimens
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Secondary outcome [1]
298737
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Integration of Reference INTERVALS into the Auckland District Health Board's Massive Transfusion Protocol to assist with the specific management of a postpartum haemorrhage.
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Assessment method [1]
298737
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Timepoint [1]
298737
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Timepoint: determined following the analyses of all venous-blood specimens
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Eligibility
Key inclusion criteria
Healthy pregnancy at term (> 37 weeks gestation)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
History of excessive bleeding
Coagulation abnormalities
Pregnancy-induced hypertension
Haematocrit < 0.31
Platelet count < 100 x 10
Abnormal liver functions
Recent anticoagulant therapy
Recent antiplatelet therapy
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/10/2010
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Actual
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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
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4484
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New Zealand
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State/province [1]
4484
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Funding & Sponsors
Funding source category [1]
285800
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Charities/Societies/Foundations
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Name [1]
285800
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A+ Charitable Trust
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Address [1]
285800
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Level 15, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
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Country [1]
285800
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New Zealand
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Primary sponsor type
Hospital
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Name
Department of Anaesthesia, National Women's
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Address
Level 9, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
284624
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None
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Name [1]
284624
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Address [1]
284624
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Country [1]
284624
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287815
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Northern X Ethics Committee
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Ethics committee address [1]
287815
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Ministry of Health
Level 3
Unisys Building
650 Great South Road
AUCKLAND 1061
NEW ZEALAND
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Ethics committee country [1]
287815
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New Zealand
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Date submitted for ethics approval [1]
287815
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09/12/2009
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Approval date [1]
287815
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01/11/2010
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Ethics approval number [1]
287815
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NTX/09/12/113
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Summary
Brief summary
This observational study measures thrombelastography (TEG) values for healthy, non-labouring, pregnant women at term. These values are analysed to provide pregnancy-specific normal range for the TEG. These normal ranges can be applied to assist with making treatment decisions during a major bleed following birth.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
34566
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Address
34566
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Country
34566
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Phone
34566
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Fax
34566
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Email
34566
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Contact person for public queries
Name
17813
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Jack Hill
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Address
17813
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Level 9, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
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Country
17813
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New Zealand
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Phone
17813
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+6492715421
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Fax
17813
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Email
17813
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[email protected]
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Contact person for scientific queries
Name
8741
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Jack Hill
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Address
8741
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Level 9, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
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Country
8741
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New Zealand
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Phone
8741
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+6492715421
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Fax
8741
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Email
8741
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[email protected]
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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.
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