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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doppler ultrasonography | Other | Radiological intervention Basic laboratory investigations, and Thrombophilia diagnosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients diagnosed with visceral venous thrombosis | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and distribution | To estimate the frequency of somatic mutations and inherited thrombophilias and describe their distribution across anatomical sites of VVT (portal, mesenteric, renal, splenic, hepatic) and underlying etiologies (autoimmune, inflammation, cirrhosis, malignancy, post-surgery, idiopathic). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with visceral venous thrombosis, including portal, mesenteric, splenic, renal and hepatic vein thrombosis in Department of Internal Medicine, Sohag University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Mahmoud I Yousef, Associate Prof. | Sohag University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag University | Sohag | 82511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38592411 | Background | Boccatonda A, Gentilini S, Zanata E, Simion C, Serra C, Simioni P, Piscaglia F, Campello E, Ageno W. Portal Vein Thrombosis: State-of-the-Art Review. J Clin Med. 2024 Mar 6;13(5):1517. doi: 10.3390/jcm13051517. | |
| 34116580 | Background | Cohen O, Caiano LM, Tufano A, Ageno W. Cancer-Associated Splanchnic Vein Thrombosis. Semin Thromb Hemost. 2021 Nov;47(8):931-941. doi: 10.1055/s-0040-1722607. Epub 2021 Jun 11. |
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| ID | Term |
|---|---|
| D017585 | Ultrasonography, Doppler, Transcranial |
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D004453 | Echoencephalography |
| D009485 | Neuroradiography |
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
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|
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011859 | Radiography |
| D014463 | Ultrasonography |
| D018608 | Ultrasonography, Doppler |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |