Clinical trial NCT03265054: Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis
Official title: Evaluation of the Predictive Value of the Microvesicle Coagulo-lytic Balance in the Recurrence of Venous Thrombosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Venous Thromboembolism (VTE)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: coagu-lytic balance of MPs
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle Desalbres
role: STUDY_DIRECTOR
References: