Thrombophilia and Thrombosis in Behçet's Disease

NCT06451575 | Recruiting

• 1 other identifier: 30.03.2023/219
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Behçet Disease

Keywords

thrombosis; thrombophilia; Behcet's disease

Outcome Measures

Primary Outcomes (7)

• Faktor II G20210A kit

  Faktor II G20210A at 200 participants

  15 months

• Faktor V Leiden kit

  Faktor V Leiden at 200 participants

  15 months

• G1691A kit

  G1691A at 200 participants

  15 months

• MTHFR (Methylene Tetra Hydro Folate Reductase) kit

  MTHFR (Methylene Tetra Hydro Folate Reductase) at 200 participants

  15 months

• C677T kit

  C677T at 200 participants

  15 months

• Factor XIII kit

  Factor XIII at 200 participants

  15 months

• With DNA isolation kit

  PAI (Plasminogen Activator Inhibitor-1) at 200 participants

  15 months

Study Arms (2)

Cases with Behcet's disease

Behcet's disease

Diagnostic Test: Blood collection

healthy individuals

Healthy control group

Diagnostic Test: Blood collection

Interventions

Blood collection DIAGNOSTIC_TEST

Blood collection

Cases with Behcet's disease; healthy individuals

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 patients with Behçet's disease aged 18-70 years and 100 age- and sex-matched healthy controls

You may qualify if:

• years old
• Patients who fulfil the international diagnostic criteria for Behçet's disease
• Those who accepted the consent form

You may not qualify if:

• Those under 18 years of age
• accompanied by another inflammatory dermatological disease
• Pregnancy and breastfeeding
• Those who use drugs that increase the tendency to thrombosis -

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Erdal Pala

Erzurum, Üniversite Mahallesi, 25240, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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 centigrade until the time of the study.

MeSH Terms

Conditions

Behcet Syndrome; Thrombosis; Thrombophilia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Embolism and Thrombosis; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• ERDAL PALA

  Ataturk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ERDAL PALA

CONTACT

+95383753661; erdal.pala@atauni.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor doctor

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)