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

Central Hospital, Nancy, France122 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

122

Conditions

Venous Thrombosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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) Exclusion Criteria: Cases and Controls : * Pregnancy * Refusal of consent * Difficulty of follow-up (not sufficient motivation)

Outcomes

Primary Outcomes

Thrombin potential measured with thrombinography

Time frame: baseline

Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)

Time frame: baseline