Thrombophilia and Thrombosis in Behçet's Disease

NCT ID: NCT06451575

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-09-01

Brief Summary

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.

Detailed Description

The study was planned as a prospective case control study. The study will be conducted on 100 Behçet's patients aged 18-70 years who were diagnosed with Behçet's disease according to the International Behçet's diagnostic criteria and 100 healthy controls similar in age and gender who applied to Atatürk University Faculty of Medicine Dermatology outpatient clinic between June 2023 and September 2024. Routine clinical evaluations of all patients will be performed. Demographic characteristics (age, gender), clinical features of the disease and medications used will be recorded. Patients will be included in the study after the relevant department consultations for system involvement. Skin and mucous membrane findings seen in the last 1 month will be recorded. Blood samples will be taken from all participants and analysed in the Genetics laboratory of our hospital. DNA isolation will be performed with DNA isolation kit from peripheral blood in EDTA tube taken from patients during routine examinations. DNA samples will be stored at -20 degrees Celsius until the time of the study. After collecting the targeted number of samples, Factor II G20210A, Factor V Leiden G1691A, MTHFR (Methylene Tetra Hydro Folate Reductase) C677T, MTHFR A1298C, Factor XIII V34L, PAI (Plasminogen Activator Inhibitor-1) 4G/5G SNP (single nucleotide polymorphisms) analyses will be performed with the thrombophilia panel kit. This analysis will be performed by fragment analysis method on the ABI 3130 Genetic analyser device in the Medical Genetics Laboratory. Firstly, PCR study will be performed with the thrombophilia panel kit, the plate with patient DNA will be loaded into the capillary electrophoresis device and the analyses will be interpreted and finalised with GeneMapper software.

Conditions

Behçet Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases with Behcet's disease

Behcet's disease

Blood collection

Intervention Type: DIAGNOSTIC_TEST

Blood collection

healthy individuals

Healthy control group

Blood collection

Intervention Type: DIAGNOSTIC_TEST

Blood collection

Interventions

Blood collection

Blood collection

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Erdal Pala

assistant professor doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ERDAL PALA

Role: PRINCIPAL_INVESTIGATOR

Ataturk University

Locations

Erdal Pala

Erzurum, Üniversite Mahallesi, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

ERDAL PALA

Role: CONTACT

erdal.pala@atauni.edu.tr

+95383753661

Facility Contacts

ERDAL PALA

Role: primary

erdalpala2525@gmail.com

+95383753661

Other Identifiers

30.03.2023/219

Identifier Type: -

Identifier Source: org_study_id