Von Willebrand Factor Levels in Patients With Liver Cirrhosis and Portal Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-12-15

Brief Summary

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Verify Von willebrand factor role in patients with liver cirrhosis and portal hypertension

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Detailed Description

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Patients with cirrhosis have an endotoxemic medium due to intestinal flora changes, decreased hepatic clearance of endotoxins and transition of bacteria to mesenteric lymph nodes from intestinal barrier .Serum Von Willebrand factor (vWF) increases in a linear ratio with the intensity of endotoxemia.

Portal hypertension (PH) is a hallmark of advanced chronic liver disease (ACLD) that significantly influences the onset of liver-related complications and mortality. It can be quantified using the minimally invasive measurement of the hepatic venous pressure gradient (HVPG). Experimental research has demonstrated that ongoing dysfunction of liver sinusoidal endothelial cells (LSEC) triggers the activation of hepatic stellate cells (HSC) and leads to intrahepatic vasoconstriction, thereby contributing to PH.

Von Willebrand factor (VWF) is released by activated endothelial cells and plays a crucial role in hemostasis by facilitating the adhesion of platelets to subendothelial collagen and other platelet-adhesive proteins exposed during vascular injury. Early studies revealed that VWF levels are elevated in patients with ACLD, linking this finding to endothelial dysfunction likely caused by endotoxemia , resulting from pathological bacterial translocation. Notably, VWF antigen (VWF-Ag) has shown diagnostic potential for clinically significant PH (CSPH; defined by an HVPG ≥ 10 mmHg) and prognostic value for disease progression, even after the underlying cause has been treated.

Elevated VWF levels may help balance the fragile hemostatic system in patients with ACLD by compensating for platelet deficiencies in number and possibly function.

VWF is more than just a hemostatic protein; it serves as a marker of endothelial dysfunction in patients with cirrhosis.VWF levels can independently predict decompensation and mortality in cirrhosis patients, regardless of the stage of liver disease and severity of portal hypertension. The VWF-to-thrombocyte ratio (VITRO) score enhances the diagnostic capability of VWF alone in noninvasively detecting CSPH.In addition to predicting the risk of hepatocellular carcinoma (HCC) in cirrhosis patients, VWF levels also forecast the risk of complications following HCC resection and response to systemic therapies.

Conditions

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Liver Cirrhosis Portal Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* adult patient \>18 years
* both sex male and female
* all stages of liver cirrhosis (compensated and decompensated)

Exclusion Criteria

* acute liver disease
* any hereditary or acquired diseases that affect VWF level.
* sepsis and infections (including spontaneous bacterial peritonitis), patients with any infectious symptoms at the time of study (increasing VWF Ag levels).
* active extrahepatic malignancies.
* previous liver transplantation.
* any medication affect VWF level.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Kerolos Sameh Jakoub Bakhet

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerolos A Sameh, Resident

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Mohamed A Ramadan, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Abdelhamid A Mohamed, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Kerolos A Sameh, Resident

Role: CONTACT

[email protected]

01280978047

Mohamed A Ramadan, Lecturer

Role: CONTACT

[email protected]

01097510010

References

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Curakova Ristovska E, Genadieva-Dimitrova M, Caloska-Ivanova V, Misevski J. Von-Willebrand factor as a predictor of three-month mortality in patients with liver cirrhosis compared to MELD score. Acta Gastroenterol Belg. 2019 Oct-Dec;82(4):487-493.

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Hametner S, Ferlitsch A, Ferlitsch M, Etschmaier A, Schofl R, Ziachehabi A, Maieron A. The VITRO Score (Von Willebrand Factor Antigen/Thrombocyte Ratio) as a New Marker for Clinically Significant Portal Hypertension in Comparison to Other Non-Invasive Parameters of Fibrosis Including ELF Test. PLoS One. 2016 Feb 19;11(2):e0149230. doi: 10.1371/journal.pone.0149230. eCollection 2016.

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Reference Type RESULT

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Mandorfer M, Simbrunner B. Prevention of First Decompensation in Advanced Chronic Liver Disease. Clin Liver Dis. 2021 May;25(2):291-310. doi: 10.1016/j.cld.2021.01.003. Epub 2021 Mar 10.

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Other Identifiers

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