ClinicalTrials.gg
Status unknownNCT03265054MICROREVEUpdated Aug 29, 2017

Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis

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

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Venous Thromboembolism (VTE)
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In context

Venous Thromboembolism

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 →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 700 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients with a VTE history with at least 3 months of anticoagulant treatment.

Exclusion criteria

Exclusion Criteria:

-

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • re-thrombosis

    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

  • no thrombosis recurrence

    adult patients with a VTE history with at least 3 months of anticoagulant treatment, without thrombosis recurrence

    Biological: Analysis of plasma samples

Interventions

  • BiologicalAnalysis of plasma samples

    Measuring microparticles (MPs) in Human Plasma Samples

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What researchers measure

Primary outcomes

  1. coagu-lytic balance of MPs

    Time frame: 12 months

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03265054
Responsible party
Sponsor
First posted
Aug 29, 2017
Start date
Sep 2017 (estimated)
Primary completion
Sep 2018 (estimated)
Completion
Sep 2019 (estimated)
Last update
Aug 29, 2017

Study contacts

Romaric Lacroix, MD
Contact
romaric.lacroix@ap-hm.fr
Urielle Desalbres
study director · Assistance Publique Hôpitaux de Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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