NCT07108023

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 31, 2025

Last Update Submit

July 31, 2025

Conditions

Keywords

Portal vein thrombosisEHPVOHypersplenismHematological disordersCoagulation profileLiver function testsCBCJAK2 mutationThrombosis in MPNCross-sectional study

Outcome Measures

Primary Outcomes (2)

  • 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

    Over a retrospective period from 2020 to 2024

  • Frequency of hematological disorders in EHPVO patients

    Over a retrospective period from 2020 to 2024

Study Arms (1)

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.

Other: No intervention (Observational Study)

Interventions

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

EHPVO Patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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 .

You may not qualify if:

  • Patients with cirrhosis or intrahepatic portal hypertension • Incomplete or missing medical records • Patients with known hematologic malignancies or undergoing chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

ThrombophiliaMyeloproliferative DisordersAntiphospholipid SyndromeHemoglobinuria, ParoxysmalThrombocytopeniaAnemiaLeukopeniaHypersplenismHematologic Diseases

Interventions

Observation

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBone Marrow DiseasesAutoimmune DiseasesImmune System DiseasesAnemia, HemolyticMyelodysplastic SyndromesBlood Platelet DisordersCytopeniaLeukocyte DisordersSplenic DiseasesLymphatic Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Mohamed Q Professor of internal medicine

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Maha M Dr Maha Mohamed Abdelaziz, Dr at Internal medicine

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rehab N Dr Rehab Nady Ali

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 6, 2025

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

August 6, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
IPD and supporting documents will be available starting 6 months after publication of the primary results and will remain available for up to 5 years after publication.
Access Criteria
Access to the de-identified individual participant data (IPD), including CBC, LFTs, and coagulation profiles, will be granted to qualified researchers for academic and non-commercial purposes. Requests should be submitted to the Principal Investigator and will be reviewed on a case-by-case basis. A data use agreement may be required before access is granted.