Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)
Not Applicable
Completed
- Conditions
- Venous Thrombosis
- Interventions
- Other: Blood sample
- Registration Number
- NCT02892565
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cases Blood sample Patients with SLE and/or APL and first vein thrombosis episode Controls Blood sample age-matched; Patients with SLE and/or APL
- Primary Outcome Measures
Name Time Method Thrombin potential measured with thrombinography baseline Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0) baseline
- Secondary Outcome Measures
Name Time Method