Extrahepatic Portal Vein Obstruction (EHPVO)EHPVO-HEMNCT07108023
Hematological Disorders in EHPVO Patients
An observational study of Extrahepatic Portal Vein Obstruction (EHPVO) and Thrombophilia, run by Rahab Nady.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extrahepatic Portal Vein Obstruction (EHPVO), Thrombophilia, Myeloproliferative Neoplasms (MPN)
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with EHPVO between 2020 and 2024 in a tertiary care hospital in Cairo. Data will be collected retrospectively from medical records
Who may be able to join
- 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 .
Who cannot join
- Patients with cirrhosis or intrahepatic portal hypertension • Incomplete or missing medical records • Patients with known hematologic malignancies or undergoing chemotherapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Study of the Spectrum of Haematological Disorders in Patients With Extrahepatic Portal Vein Obstruction
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.
Read the detailed description
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.
- Conditions
- Extrahepatic Portal Vein Obstruction (EHPVO), Thrombophilia, Myeloproliferative Neoplasms (MPN), Antiphospholipid Syndrome (APS), Paroxysmal Nocturnal Hemoglobinuria (PNH), Thrombocytopenia
- Being tested
- No intervention (Observational Study)
- Keywords
- Portal vein thrombosis, EHPVO, Hypersplenism, Hematological disorders, Coagulation profile, Liver function tests, CBC, JAK2 mutation, Thrombosis in MPN, Cross-sectional study
- Medical subject headings
- Thrombophilia, Myeloproliferative Disorders, Antiphospholipid Syndrome, Hemoglobinuria, Paroxysmal, Thrombocytopenia, Anemia, Leukopenia, Hypersplenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (Observational Study)Other
This is a retrospective observational study with no assigned intervention. Data will be collected from patient medical records only
| Study group | Role | What they receive |
|---|---|---|
| EHPVO Patients | Patients diagnosed with extrahepatic portal vein obstruction (EHPVO) based on imaging (Doppler ultrasound, CT, or MRI) and with preserved liver function. This group will be assessed for hematological abnormalities, including cytopenias and coagulation disturbances, using retrospective laboratory data. Receives: Other: No intervention (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hematological disorders in EHPVO patients
The proportion of EHPVO Patients showing hematological disorders including cytopenias ( thrombocytopenia , anemia , leukopenia ) and coagulation disturbances based on retrospective laboratory data
Measured: Over a retrospective period from 2020 to 2024
Frequency of hematological disorders in EHPVO patients
Measured: Over a retrospective period from 2020 to 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic Portal Vein Obstruction (EHPVO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rahab Nady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rahab Nady, Assiut University
- Investigators
- Mohamed Q Professor of internal medicine, Principal investigator, Assiut UniversityMaha M Dr Maha Mohamed Abdelaziz, Dr at Internal medicine, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108023
- Sponsor's protocol ID
- EHPVO-02
- Acronym
- EHPVO-HEM
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including complete blood count (CBC), liver function tests (LFTs), and coagulation profile results, will be shared. No personally identifiable information will be included.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Spectrum of Haematological Disorders in Patients With Extrahepatic Portal Vein Obstruction
- ClinicalTrials.gov ID
- NCT07108023
- Acronym / sponsor ID
- EHPVO-HEM / EHPVO-02
- Conditions
- Extrahepatic Portal Vein Obstruction (EHPVO), Thrombophilia, Myeloproliferative Neoplasms (MPN), Antiphospholipid Syndrome (APS), Paroxysmal Nocturnal Hemoglobinuria (PNH), Thrombocytopenia
- Keywords
- Portal vein thrombosis, EHPVO, Hypersplenism, Hematological disorders, Coagulation profile, Liver function tests, CBC, JAK2 mutation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Rahab NadyUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EHPVO Patients | – | Other: No intervention (Observational Study)Patients diagnosed with extrahepatic portal vein obstruction (EHPVO) based on imaging (Doppler ultrasound, CT, or MRI) and with preserved liver function. This group will be assessed for hematological abnormalities, including cytopenias and coagulation disturbances, using retrospective laboratory data. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with EHPVO between 2020 and 2024 in a tertiary care hospital in Cairo. Data will be collected retrospectively from medical records
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- Patients with cirrhosis or intrahepatic portal hypertension • Incomplete or missing medical records • Patients with known hematologic malignancies or undergoing chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (Observational Study)This is a retrospective observational study with no assigned intervention. Data will be collected from patient medical records only | Other | EHPVO Patients |
Primary outcome
Frequency of hematological disorders in EHPVO patients
Time frame: Over a retrospective period from 2020 to 2024
The proportion of EHPVO Patients showing hematological disorders including cytopenias ( thrombocytopenia , anemia , leukopenia ) and coagulation disturbances based on retrospective laboratory data
Frequency of hematological disorders in EHPVO patients
Time frame: Over a retrospective period from 2020 to 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including complete blood count (CBC), liver function tests (LFTs), and coagulation profile results, will be shared. No personally identifiable information will be included.
Related trials for Extrahepatic Portal Vein Obstruction (EHPVO)
Enrolling by invitation
Radiological Intervention for Childhood Extra-Hepatic Portal Vein Obstruction
Extrahepatic Portal Vein Obstruction (EHPVO)
Active, not recruitingObservational study
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
Hypertension, Portal, Interventional Radiology
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Q Professor of internal medicine principal investigator
Assiut University
Maha M Dr Maha Mohamed Abdelaziz, Dr at Internal medicine principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Extrahepatic Portal Vein Obstruction (EHPVO) and Thrombophilia, run by Rahab Nady.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rehab N Dr Rehab Nady Ali (+201099703970, reeehabnady@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hematological disorders in EHPVO patients (time frame: Over a retrospective period from 2020 to 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.