ClinicalTrials.gov record NCT07108023
Hematological Disorders in EHPVO Patients
A Prospective Study of the Spectrum of Haematological Disorders in Patients With Extrahepatic Portal Vein Obstruction
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective observational study of people with extrahepatic portal vein obstruction (EHPVO). Researchers will review past medical records and lab results to describe blood cell counts, liver tests, and clotting profiles. The study looks for patterns that might point to underlying blood disorders such as MPN, APS, or PNH and how these relate to clinical outcomes.
What it is studying. Whether laboratory patterns in routine blood, liver, and clotting tests in people with EHPVO are associated with underlying hematological disorders (for example MPN, APS, or PNH) and related clinical outcomes.
What the researchers hope to learn. Measure how often hematological abnormalities appear in patients with EHPVO. Correlate laboratory findings with diagnoses of specific blood disorders. Evaluate links between these abnormalities and clinical outcomes such as variceal bleeding, transfusion needs, and prognosis. Provide data to inform future research and consideration of thrombophilia screening in this population.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study focuses on patients who have a condition called extrahepatic portal vein obstruction (EHPVO), where a blood clot blocks the portal vein outside the liver. This blockage can cause problems like an enlarged spleen, bleeding from swollen veins in the digestive system, and low blood cell counts. Many of these patients may have hidden blood disorders that increase the risk of clotting, such as myeloproliferative neoplasms (MPNs), antiphospholipid syndrome (APS), or paroxysmal nocturnal hemoglobinuria (PNH). This study will collect and analyze blood test results-such as complete blood count (CBC), liver function tests (LFTs), and clotting tests-from patients with EHPVO. The aim is to find patterns that may suggest an underlying blood disorder, even if the patient doesn't show obvious symptoms.By understanding these patterns early, doctors may be able to diagnose and treat the root causes of clotting in these patients more accurately, helping prevent complications and improve outcomes.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- No intervention (Observational Study)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age 18 years or older . Diagnosis of extra hepatic portal vein obstruction based on imaging ( Doppler, CT , MRI ) preserved liver function . Available complete medical records including CBC , LFTs and coagulation profile .
Exclusion criteria
- Patients with cirrhosis or intrahepatic portal hypertension • Incomplete or missing medical records • Patients with known hematologic malignancies or undergoing chemotherapy
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Extrahepatic portal vein obstruction (EHPVO) is a non-cirrhotic cause of portal hypertension that results from a thrombotic blockade in the portal vein outside the liver. The preserved hepatic parenchyma distinguishes EHPVO from intrahepatic causes of portal hypertension. However, complications like variceal bleeding, hypersplenism, and splenomegaly remain common. Hematological abnormalities frequently observed in EHPVO include thrombocytopenia, anemia, and leukopenia, often attributed to hypersplenism. Yet, in a subset of patients, especially those with concurrent myeloproliferative neoplasms (MPNs), these cytopenias may be masked due to increased production of blood elements. Coagulation profiles may also show subtle abnormalities or evidence of underlying thrombophilia.A growing body of literature suggests a strong association between EHPVO and underlying prothrombotic conditions such as MPNs (often linked to JAK2V617F mutation), antiphospholipid syndrome (APS), and paroxysmal nocturnal hemoglobinuria (PNH). Early identification of these disorders may significantly impact clinical management, prognosis, and long-term surveillance. The current study is a cross-sectional observational analysis aiming to investigate the hematological spectrum in patients with EHPVO at Assiut University Hospital. Data will be collected retrospectively from medical records, including CBC with differential, liver function tests, coagulation parameters, and specific thrombophilia workups when available. The primary objective is to correlate these laboratory findings with underlying hematological disorders. Secondary aims include evaluating the association between these abnormalities and clinical outcomes such as variceal bleeding, transfusion needs, and prognosis. The study may offer valuable insights into risk stratification and highlight the importance of thrombophilia screening in this patient population.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a retrospective observational study using existing medical records only; no new tests, procedures, treatments, or study visits are performed. The study team will extract information already in the chart—such as complete blood counts, liver tests, clotting tests, thrombophilia workups when available, and clinical outcomes (e.g., bleeding, transfusions). Participants will not undergo extra procedures for the study.
How the study is structured. A retrospective, case-only observational review: researchers will collect and analyze existing medical records and laboratory data from people diagnosed with EHPVO between 2020 and 2024. No treatments or new tests are given.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on paroxysmal nocturnal hemoglobinuria
Important dates
- Study start
- August 2025 (estimated)
- Primary completion
- December 2025 (estimated)
- Study completion
- December 2025 (estimated)
- Target enrollment
- 115 participants (estimated)
- Last updated on registry
- Aug 6, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Rahab Nady
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Rehab N Dr Rehab Nady Ali 📞 +201099703970 ✉ reeehabnady@gmail.com
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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