Genetic Drivers,Risk Factors and Management Strategies on Survival and Clinical Outcomes in Visceral Venous "Thrombosis"

Sohag University

Status: Active, not recruiting

Conditions: Visceral Venous Thrombosis

Treatments: Other: Doppler ultrasonography

Study type: Observational

Funder types: Other

Identifiers

NCT07329725

Visceral Venous Thrombosis

Details and patient eligibility

About

This study aims to evaluate the impact of genetic drivers (somatic and inherited thrombophilias), acquired risk factors, and management strategies on survival and clinical outcomes in patients with VVT using a hybrid prospective-retrospective cohort design.

Full description

Observational study (hybrid study comprising a retrospective and prospective cohort analysis):

To evaluate the impact of genetic drivers (somatic and inherited thrombophilias), acquired risk factors, and management strategies on survival and clinical outcomes in patients with VVT using a hybrid prospective-retrospective cohort design.

Data will be collected from the Department of Internal Medicine/hematology unit at Sohag University hospital and clinical databases.

The retrospective component will include eligible patients diagnosed within the preceding ten years, whereas the prospective component will enroll newly diagnosed patients and follow them for one year.

1. Retrospective Cohort Analysis:

   Review of medical records to analyze demographic, clinical, and molecular data. Assessment of treatment regimens and outcomes, including thrombotic events, disease progression, and survival rates.

2. Prospective Cohort Analysis:

Consecutive patients will be diagnosed with VVT from [date of ethical approval] forward, enrolled at diagnosis and followed prospectively with standardized baseline testing (including comprehensive genetic panel) and predefined follow-up visits.

Enrollment: 101 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients (≥ 18 years) with radiologically confirmed visceral venous thrombosis.
• Availability of complete clinical, laboratory, and imaging data at diagnosis.
• Patients who consent to participate and provide blood samples for genetic testing.

Exclusion criteria

• Isolated lower-limb deep-vein thrombosis or pulmonary embolism without visceral involvement.
• Patients with incomplete records precluding outcome assessment.
• Refusal or inability to provide informed consent
• Patients lost to follow-up within the first three months of diagnosis.

Trial design

101 participants in 2 patient groups

Retrospective Cohort Analysis

Description:

Review of medical records to analyze demographic, clinical, and molecular data. Assessment of treatment regimens and outcomes, including thrombotic events, disease progression, and survival rates.

Treatment:

Other: Doppler ultrasonography

Prospective Cohort Analysis

Description:

Consecutive patients will be diagnosed with VVT from \[date of ethical approval\] forward, enrolled at diagnosis and followed prospectively with standardized baseline testing (including comprehensive genetic panel) and predefined follow-up visits.

Treatment:

Other: Doppler ultrasonography