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Liver CirrhosisNCT06694090

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

An observational study of Liver Cirrhosis and Portal Hypertension, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Verify Von willebrand factor role in patients with liver cirrhosis and portal hypertension Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Liver Cirrhosis, Portal Hypertension
How many people
67 participants
Where
No sites listed yet
Study dates
15 Nov 2024to 15 Dec 2025
How long will I take part?
20 Days
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 65 years
  • All sexes
  • Adult, Older adult

Study population: All patients aged 18-65 years with all stages of liver cirrhosis (compensated and decompensated)

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Kerolos A Sameh, Resident contact

01280978047

kerosameh752@gmail.com

Mohamed A Ramadan, Lecturer contact

01097510010

drmuhamedramadan@yahoo.com

About this study

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

Read the detailed description

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.

Keywords
Von willebrand factor, Liver cirrhosis, Portal hypertension
Medical subject headings
Liver Cirrhosis, Hypertension, Portal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Verify Von willebrand factor role in patients with liver cirrhosis and portal hypertension by using VWF-Ag concentation and fibroscan

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2024
  2. Study start15 Nov 2024 (estimated)
  3. Primary completion15 Nov 2025 (estimated)
  4. Study completion15 Dec 2025 (estimated)

Resources

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
Other
Time perspective
Cross-sectional
Enrolment
67 participants (estimated)
Target duration
20 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06694090
Sponsor's protocol ID
Von willebrand factor levels
Status last verified
Nov 2024
First submitted
14 Nov 2024
Last updated
19 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Foucher J, Chanteloup E, Vergniol J, Castera L, Le Bail B, Adhoute X, Bertet J, Couzigou P, de Ledinghen V. Diagnosis of cirrhosis by transient elastography (FibroScan): a prospective study. Gut. 2006 Mar;55(3):403-8. doi: 10.1136/gut.2005.069153. Epub 2005 Jul 14.

    PubMed 16020491

  • 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.

    PubMed 31950803

  • 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.

    PubMed 26895398

  • van den Boom BP, Stamouli M, Timon J, Bernal W, Blasi A, Adelmeijer J, Fernandez J, Lisman T, Patel VC. Von Willebrand factor is an independent predictor of short-term mortality in acutely ill patients with cirrhosis. Liver Int. 2023 Dec;43(12):2752-2761. doi: 10.1111/liv.15728. Epub 2023 Sep 16.

    PubMed 37715606

  • Elhence A, Shalimar. Von Willebrand Factor as a Biomarker for Liver Disease - An Update. J Clin Exp Hepatol. 2023 Nov-Dec;13(6):1047-1060. doi: 10.1016/j.jceh.2023.05.016. Epub 2023 Jun 2.

    PubMed 37975050

  • Lisman T, Bongers TN, Adelmeijer J, Janssen HL, de Maat MP, de Groot PG, Leebeek FW. Elevated levels of von Willebrand Factor in cirrhosis support platelet adhesion despite reduced functional capacity. Hepatology. 2006 Jul;44(1):53-61. doi: 10.1002/hep.21231.

    PubMed 16799972

  • Pomej K, Scheiner B, Balcar L, Nussbaumer RJ, Weinzierl J, Paternostro R, Simbrunner B, Bauer D, Pereyra D, Starlinger P, Stattermayer AF, Pinter M, Trauner M, Quehenberger P, Reiberger T, Mandorfer M. Clinical significance of substantially elevated von Willebrand factor antigen levels in patients with advanced chronic liver disease. Dig Liver Dis. 2022 Oct;54(10):1376-1384. doi: 10.1016/j.dld.2022.06.010. Epub 2022 Jul 22.

    PubMed 35871985

  • Mandorfer M, Schwabl P, Paternostro R, Pomej K, Bauer D, Thaler J, Ay C, Quehenberger P, Fritzer-Szekeres M, Peck-Radosavljevic M, Trauner M, Reiberger T, Ferlitsch A; Vienna Hepatic Hemodynamic Lab. Von Willebrand factor indicates bacterial translocation, inflammation, and procoagulant imbalance and predicts complications independently of portal hypertension severity. Aliment Pharmacol Ther. 2018 Apr;47(7):980-988. doi: 10.1111/apt.14522. Epub 2018 Jan 29.

    PubMed 29377193

  • Mandorfer M, Hernandez-Gea V, Garcia-Pagan JC, Reiberger T. Noninvasive Diagnostics for Portal Hypertension: A Comprehensive Review. Semin Liver Dis. 2020 Aug;40(3):240-255. doi: 10.1055/s-0040-1708806. Epub 2020 Jun 18.

    PubMed 32557480

  • Carnevale R, Raparelli V, Nocella C, Bartimoccia S, Novo M, Severino A, De Falco E, Cammisotto V, Pasquale C, Crescioli C, Scavalli AS, Riggio O, Basili S, Violi F. Gut-derived endotoxin stimulates factor VIII secretion from endothelial cells. Implications for hypercoagulability in cirrhosis. J Hepatol. 2017 Nov;67(5):950-956. doi: 10.1016/j.jhep.2017.07.002. Epub 2017 Jul 14.

    PubMed 28716745

  • Ferro D, Quintarelli C, Lattuada A, Leo R, Alessandroni M, Mannucci PM, Violi F. High plasma levels of von Willebrand factor as a marker of endothelial perturbation in cirrhosis: relationship to endotoxemia. Hepatology. 1996 Jun;23(6):1377-83. doi: 10.1002/hep.510230613.

    PubMed 8675154

  • van der Vorm LN, Remijn JA, de Laat B, Huskens D. Effects of Plasmin on von Willebrand Factor and Platelets: A Narrative Review. TH Open. 2018 Jun 7;2(2):e218-e228. doi: 10.1055/s-0038-1660505. eCollection 2018 Apr.

    PubMed 31249945

  • Garcia-Pagan JC, Gracia-Sancho J, Bosch J. Functional aspects on the pathophysiology of portal hypertension in cirrhosis. J Hepatol. 2012 Aug;57(2):458-61. doi: 10.1016/j.jhep.2012.03.007. Epub 2012 Apr 12. No abstract available.

    PubMed 22504334

  • 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.

    PubMed 33838851

  • Yilmaz VT, Dincer D, Avci AB, Cetinkaya R. Significant Association between Serum Levels of Von Willebrand Factor (vWF) Antigen with Stages of Cirrhosis. Eurasian J Med. 2015 Feb;47(1):21-5. doi: 10.5152/eajm.2014.0016.

    PubMed 25745341

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cirrhosis and Portal Hypertension, run by Assiut University.

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 3 inclusion and 6 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 19 Nov 2024. 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 Kerolos A Sameh, Resident (01280978047, kerosameh752@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verify Von willebrand factor role in patients with liver cirrhosis and portal hypertension by using VWF-Ag concentation and fibroscan (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06694090, which also lists 15 linked publications.

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 19 Nov 2024.

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