Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2009-12-31

Brief Summary

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The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. This is a case-control study in a population with patients having systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL).

Secondary purposes are:

1. To determine the frequency of hypercoagulable phenotype in study population;
2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk;
3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.

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Detailed Description

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Conditions

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Venous Thrombosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Cases

Patients with SLE and/or APL and first vein thrombosis episode

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

Controls

age-matched; Patients with SLE and/or APL

Group Type OTHER

Blood sample

Intervention Type OTHER

Interventions

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Blood sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Cases :

* Patients with SLE and/or APL and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years)
* Any weight and height
* Absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having APL; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment

Controls:

* Patients with SLE and/or APL without thrombosis (venous or arterial)
* Any weight and height
* Possibility of platelet function inhibitory treatment (primary prophylaxis of arterial manifestations)