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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.
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.
Secondary ID [1] 281012 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive Health and Childbirth 287146 0
Blood Clotting 287172 0
Condition category
Condition code
Blood 287467 287467 0 0
Clotting disorders
Reproductive Health and Childbirth 287501 287501 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 285471 0
Not applicable
Comparator / control treatment
Native
Control group
Active

Outcomes
Primary outcome [1] 287735 0
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.
Timepoint [1] 287735 0
Timepoint: Point-of-care analyses ensure immediate processing
Primary outcome [2] 287736 0
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.
Timepoint [2] 287736 0
Timepoint: determined following the analyses of all venous-blood specimens
Secondary outcome [1] 298737 0
Integration of Reference INTERVALS into the Auckland District Health Board's Massive Transfusion Protocol to assist with the specific management of a postpartum haemorrhage.
Timepoint [1] 298737 0
Timepoint: determined following the analyses of all venous-blood specimens

Eligibility
Key inclusion criteria
Healthy pregnancy at term (> 37 weeks gestation)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

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 outside Australia
Country [1] 4484 0
New Zealand
State/province [1] 4484 0

Funding & Sponsors
Funding source category [1] 285800 0
Charities/Societies/Foundations
Name [1] 285800 0
A+ Charitable Trust
Address [1] 285800 0
Level 15, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
Country [1] 285800 0
New Zealand
Primary sponsor type
Hospital
Name
Department of Anaesthesia, National Women's
Address
Level 9, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284624 0
None
Name [1] 284624 0
Address [1] 284624 0
Country [1] 284624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287815 0
Northern X Ethics Committee
Ethics committee address [1] 287815 0
Ministry of Health
Level 3
Unisys Building
650 Great South Road
AUCKLAND 1061
NEW ZEALAND
Ethics committee country [1] 287815 0
New Zealand
Date submitted for ethics approval [1] 287815 0
09/12/2009
Approval date [1] 287815 0
01/11/2010
Ethics approval number [1] 287815 0
NTX/09/12/113

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34566 0
Address 34566 0
Country 34566 0
Phone 34566 0
Fax 34566 0
Email 34566 0
Contact person for public queries
Name 17813 0
Jack Hill
Address 17813 0
Level 9, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
Country 17813 0
New Zealand
Phone 17813 0
+6492715421
Fax 17813 0
Email 17813 0
jackshill@xtra.co.nz
Contact person for scientific queries
Name 8741 0
Jack Hill
Address 8741 0
Level 9, Building 1, Auckland City Hospital
2 Park Road
Grafton, Auckland 1023
New Zealand
Country 8741 0
New Zealand
Phone 8741 0
+6492715421
Fax 8741 0
Email 8741 0
jackshill@xtra.co.nz

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