Impact of Genetic Drivers, Acquired Risk Factors, and Management Strategies on Survival and Clinical Outcomes in Visceral Venous Thrombosis
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Sohag University
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Patients diagnosed with visceral venous thrombosis
Overview
Brief Summary
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.
Detailed 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.
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Patients diagnosed with visceral venous thrombosis
Time Frame: 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.
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.
Secondary Outcomes
- Frequency and distribution(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.)
Investigators
Fatma mohamed Ahmed Anwer
Principal Investigator
Sohag University