NCT06694090

Brief Summary

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

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
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

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

November 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 14, 2024

Last Update Submit

November 16, 2024

Conditions

Keywords

Von willebrand factorLiver cirrhosisPortal hypertension

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kerolos A Sameh, Resident

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Mohamed A Ramadan, Lecturer

    Assiut University

    STUDY DIRECTOR
  • Abdelhamid A Mohamed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Kerolos A Sameh, Resident

CONTACT

Mohamed A Ramadan, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
20 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 19, 2024

Study Start

November 15, 2024

Primary Completion

November 15, 2025

Study Completion

December 15, 2025

Last Updated

November 19, 2024

Record last verified: 2024-11