RecruitingACTRN12619000050156

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?

Does a correlation exist with either rotational thromboelastometry (ROTEM) or Thrombin Generation Assay and a venous thromboembolism risk assessment chart?


Sponsor

Darren Lowen

Enrollment

130 participants

Start Date

Feb 25, 2019

Study Type

Observational

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Blood clots in the veins (deep vein thrombosis or DVT) are a known risk in women who have recently given birth. Hospitals use a risk assessment chart to classify women as low, medium, or high risk, and those deemed medium or high risk receive blood-thinning injections (enoxaparin) to prevent clots. However, approximately 30% of women who do develop a blood clot were originally categorised as low risk — meaning some at-risk women may be missed. This study examines whether a blood test using a machine that measures how easily blood clots (a viscoelastic test) can better identify postpartum women who are at risk of developing a blood clot, beyond what the current chart alone can predict. A small blood sample is taken within 60 minutes of delivering the placenta. You may be eligible if you have just given birth to a live baby at The Northern Hospital and are able to provide informed consent shortly after delivery. Women who are unable to consent or whose baby was stillborn are not included. This is a cross-sectional observational study — participation involves only a single blood sample.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 f

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.


Locations(1)

The Northern Hospital - Epping

VIC, Australia

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ACTRN12619000050156