Hematological Disorders in EHPVO Patients

NCT ID: NCT07108023

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 115 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2025-12-31

Brief 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. 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.

Conditions

Extrahepatic Portal Vein Obstruction (EHPVO); Thrombophilia; Myeloproliferative Neoplasms (MPN); Antiphospholipid Syndrome (APS); Paroxysmal Nocturnal Hemoglobinuria (PNH); Thrombocytopenia; Anemia; Leukopenia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No intervention (Observational Study)

Intervention Type: OTHER

This is a retrospective observational study with no assigned intervention. Data will be collected from patient medical records only

Interventions

No intervention (Observational Study)

This is a retrospective observational study with no assigned intervention. Data will be collected from patient medical records only

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rahab Nady

OTHER

Sponsor Role: lead

Responsible Party

Rahab Nady

Assistant Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mohamed Q Professor of internal medicine

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Maha M Dr Maha Mohamed Abdelaziz, Dr at Internal medicine

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Rehab N Dr Rehab Nady Ali

Role: CONTACT

reeehabnady@gmail.com

+201099703970

Related Links

https://emedicine.medscape.com/article/182425-overview?form=fpf

Related Info

Other Identifiers

EHPVO-02

Identifier Type: -

Identifier Source: org_study_id