Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000050156
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
15/01/2019
Date last updated
17/12/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Is there an association between a postpartum venous thromboembolism risk assessment chart and the results of either two different means of determining clot formation, using a sample of blood?
Scientific title
Does a correlation exist with either rotational thromboelastometry (ROTEM) or Thrombin Generation Assay and a venous thromboembolism risk assessment chart?
Secondary ID [1] 297004 0
Nil known
Universal Trial Number (UTN)
U1111-1226-3787
Trial acronym
The CLOT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Risk assessment of deep vein thrombosis in postpartum women 310998 0
Condition category
Condition code
Reproductive Health and Childbirth 309650 309650 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All women who birth at The Northern Hospital are scored using the postpartum venous thromboembolism risk assessment chart, which will then assign the women to being at low, intermediate or high risk for the development of deep vein thrombosis. For the first 130 individuals who consent to the request for a sample of blood, the clotting capability of the sampled blood will be tested using ROTEM and the Thrombin Generation Assay. This blood sample is not part of routine care of postpartum women. We are trying to determine if there is any correlation between the class of risk assigned using the postpartum venous thomboembolism risk assessment chart and 'clotability' of blood as determined both by ROTEM and the Thrombin Generation Assay. There is no time frame that the participants are observed for, however, the blood sample needs to be withdrawn within 60 minutes of delivery of the placenta.
Intervention code [1] 313297 0
Not applicable
Comparator / control treatment
Not applicable. No control group. All women who give birth at The Northern Hospital have a risk assessment for the development of a deep vein thrombosis, the risk assigned is either low, intermediate or how. For the first 130 women who volunteer for the withdrawal of a sample of blood, we will determine the clotability of the blood with both ROTEM and the Thrombin Generation Assay. Data from both of these in vitro tests will be used to determine if either or both results correlate with the risk category assigned. Therefore, there is no control group and we are not comparing the results of ROTEM with the results of the Thrombin Generation Assay.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318607 0
Venous thromboembolism risk assessment as assessed by clot strength determined by the use of ROTEM
Timepoint [1] 318607 0
The primary timepoint is within one hour post delivery of the placenta
Primary outcome [2] 318666 0
Venous thromboembolism risk assessment, as measured by blood 'clotability', using the Thrombin Generation Assay
Timepoint [2] 318666 0
Within one hour post delivery of the placenta
Secondary outcome [1] 365516 0
There are no secondary outcomes
Timepoint [1] 365516 0
Not applicable

Eligibility
Key inclusion criteria
Postpartum of a live neonate, within 60 minutes of the delivery of the placenta, in an individual who has capacity to consent to the request for a sample of blood
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to provide consent for the request of a sample of blood and fetal death at the time of birth

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Initial analysis of the data will be by the generation of scatter plots. If a linear correlation is shown to exist, we will use Pearson product moment correlation coefficient (r). If the data are not normal, we will use Spearman Rank Order Correlation (rho) instead.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
25/02/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
29/02/2020
Actual
Sample size
Target
130
Accrual to date
109
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12845 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 25320 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 301575 0
Commercial sector/Industry
Name [1] 301575 0
Ferring Pharmaceutical
Country [1] 301575 0
Australia
Primary sponsor type
Individual
Name
Darren Lowen
Address
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping, VIC, 3076
Country
Australia
Secondary sponsor category [1] 301285 0
None
Name [1] 301285 0
Address [1] 301285 0
Country [1] 301285 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302304 0
Austin Health HREC
Ethics committee address [1] 302304 0
The Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 302304 0
Australia
Date submitted for ethics approval [1] 302304 0
12/12/2018
Approval date [1] 302304 0
08/01/2019
Ethics approval number [1] 302304 0
HREC/49067/Austin-2018

Summary
Brief summary
This study is a cross-sectional study of the first 130 women who deliver a live fetus at The Northern Hospital. All women who give birth at The Northern Hospital are assigned a risk category for the subsequent likelihood of developing a deep vein thrombosis within the first 6 weeks post birth. The risk categories are low, intermediate and high. Women who are assigned an intermediate risk receive enoxaparin subcutaneously for the first 5 days after giving birth, whereas those women who are assigned a high risk, will need to receive enoxaparin for the first 6 weeks post birth. Women who are categorised as being of low risk, do not receive enoxaparin. Unfortunately though, approximately 30 % of women who actually develop a deep vein thrombosis are categorised as being of low risk. Therefore, as an initial first step, we would like to determine if a machine, which determines the clotability of blood may also be used to assign a risk category for the subsequent development of deep vein thrombosis in women who have recently given birth. A positive result may allow us to to identify the 30% of women who are incorrectly categorised as being of low risk.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89758 0
Dr Darren Lowen
Address 89758 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 89758 0
Australia
Phone 89758 0
+61 03 8405 8521
Fax 89758 0
+61 03 8405 8032
Email 89758 0
[email protected]
Contact person for public queries
Name 89759 0
Dr Darren Lowen
Address 89759 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 89759 0
Australia
Phone 89759 0
+61 03 8405 8521
Fax 89759 0
+61 03 8405 8032
Email 89759 0
[email protected]
Contact person for scientific queries
Name 89760 0
Dr Darren Lowen
Address 89760 0
Department of Anaesthesia and Perioperative Medicine
The Northern Hospital
185 Cooper Street
Epping VIC 3076
Country 89760 0
Australia
Phone 89760 0
+61 03 8405 8521
Fax 89760 0
+61 03 8405 8032
Email 89760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial after it has been de-identified
When will data be available (start and end dates)?
Immediately following publication and ending 7 years post main results publication
Available to whom?
On a case by case basis at the discretion of the Primary Sponsor and approval by ethics and local governance
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approval by Principal Investigator


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.