An observational study in Venous Thromboembolism (VTE), sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-29.
Sponsored by Assistance Publique Hopitaux De Marseille · Observational
Venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) affects about 1,200,000 individuals each year in Europe. About 50% of VTE are unprovoked and 20% of these patients will face a recurrent event after the usual three to six-month course of anticoagulant treatment. To date, most patients are given prolonged anticoagulant treatment. However, anticoagulant treatment are associated with a major risk of bleeding (3%/year). Thus an accurate identification of patients with unprovoked VTE with a low risk of recurrence is needed to avoid unnecessary anticoagulant treatment with a risk of bleeding.
Over the past few years, microparticles (MPs) which are small vesicles originating from the budding of cellular membranes have emerged as important biological entities regulating hemostasis. MPs expose at their surface procoagulant molecules such as phosphatidylserin and tissue factor (TF). All data obtained in mouse models support a role of MPs in venous thrombosis mediated by the TF activation. Moreover, results from clinical studies showed that TF-MPs was associated with the risk of venous thrombosis. However, the predictive value of TF-MPs in the recurrence of VTE is unknown. Besides, no study has taken into account the recent progresses in the understanding of the role of MPs in haemostasis. Indeed, MPs vectorize molecules which are not only procoagulant but also profibrinolytic. The net result depends on a balance between both activities (the coagulo-lytic balance). This balance is can be measured by two complimentary assays on MPs.
We hypothesized that the coagu-lytic balance of MPs is associated with an increased risk of VTE recurrence after stopping the anticoagulant treatment.
708 studies on the registry are indexed under Venous Thromboembolism; 152 are open to participants now.
This study's planned enrollment of 300 is below the median of 630 across 289 observational studies indexed under Venous Thromboembolism.
Browse Venous Thromboembolism studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.
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300 adult patients with a VTE history with at least 3 months of anticoagulant treatment. 150 patients which suffered from a re-thrombosis within 5 years after stopping the anticoagulant treatment, will be age- and sex-matched with 150 without thrombosis recurrence.
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Exclusion Criteria:
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adult patients with a VTE history with at least 3 months of anticoagulant treatment, which suffered from a re-thrombosis within 5 years after stopping the anticoagulant treatment
Biological: Analysis of plasma samples
adult patients with a VTE history with at least 3 months of anticoagulant treatment, without thrombosis recurrence
Biological: Analysis of plasma samples
Measuring microparticles (MPs) in Human Plasma Samples
coagu-lytic balance of MPs
Time frame: 12 months
This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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