Behçet Disease Clinical Trial
Official title:
Thrombophilia and Tendency to Thrombosis in Behçet's Disease
Behçet's disease (BD) is a systemic vasculitis of unknown cause, affecting mainly young adults. Vasculopathy has been reported in 16.8-51.5% of cases. Genetic, infectious factors, environmental factors, presence of autoantibodies, endothelial pathologies and hypercoagulability are responsible for the etiopathogenesis of BD. The main involvements responsible for morbidity and mortality in Behçet's disease are ocular, major cardiovascular and neurological involvements. Although there is an increased thrombotic risk in the etiopathogenesis of Behçet's disease, the cellular and molecular mechanisms are not fully understood. Although endothelial dysfunction due to inflammation has been shown to be the primary cause of vascular damage in Behçet's disease, some clinical evidence suggests that hypercoagulable states also contribute to thrombosis. The most common form of vascular involvement in Behçet's disease is deep vein thrombosis in the lower extremities. Arterial occlusion mostly affects the subclavian and pulmonary arteries. Although arterial involvement is rarer than venous involvement in Behçet's disease, morbidity and mortality are higher than venous involvement. Although an increased thrombotic risk is mentioned in the etiopathogenesis of Behçet's disease, it is still controversial whether vasculitis or susceptibility to hypercoagulability plays a role in the pathogenesis of venous thrombosis. In addition, there are very few studies in the literature in which all thrombophilic parameters were analysed. Again, there is no recent study on this subject. The aim of our study is to determine the risk of hypercoagulability in Behçet's disease patients with vascular involvement, which has a highly mortal course.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | September 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. 18-70 years old 2. Patients who fulfil the international diagnostic criteria for Behçet's disease 3. Those who accepted the consent form Exclusion Criteria: 1. Those under 18 years of age 2. accompanied by another inflammatory dermatological disease 3. Pregnancy and breastfeeding 4. Those who use drugs that increase the tendency to thrombosis - |
Country | Name | City | State |
---|---|---|---|
Turkey | Erdal Pala | Erzurum | Üniversite Mahallesi |
Lead Sponsor | Collaborator |
---|---|
Ataturk University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Faktor II G20210A kit | Faktor II G20210A at 200 participants | 15 months | |
Primary | Faktor V Leiden kit | Faktor V Leiden at 200 participants | 15 months | |
Primary | G1691A kit | G1691A at 200 participants | 15 months | |
Primary | MTHFR (Methylene Tetra Hydro Folate Reductase) kit | MTHFR (Methylene Tetra Hydro Folate Reductase) at 200 participants | 15 months | |
Primary | C677T kit | C677T at 200 participants | 15 months | |
Primary | Factor XIII kit | Factor XIII at 200 participants | 15 months | |
Primary | With DNA isolation kit | PAI (Plasminogen Activator Inhibitor-1) at 200 participants | 15 months |
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