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Completed

NCT Number: NCT04267406

ADAMTS-13 and Von Willebrand Factor Levels and Activities in Children With Cirrhosis and/or Portal Hypertension

Hemostasis-related disorders are common in cirrhosis and portal hypertension. However, it is not known whether the net effect of changes in hemostasis in the sense of predisposition to hemorrhagic or thrombotic state. It is suggested that increasing the concentration and activities of Von Willebrand factor (vWF) and decline ADAMTS-13 (A Disintegrin and Metalloproteinase with Trombospondin type 1 motif, member 13) may cause thrombophilic changes in cirrhosis and portal hypertension. The aim of this study was to investigate the changes in ADAMTS-13 (A disintegrin and metalloproteinase with thrombospondin motifs 13) and von willebrand factor (vWF) levels and activities in patients with cirrhosis and portal hypertension.

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Key information

Conditions

Coagulation Disorder Cardiovascular Diseases Cirrhosis, Liver Digestive System Diseases Fibrosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ataturk University Hospital

Erzurum, 25240, Turkey (Türkiye)

About this study

Patients of 3 months to 18 years of age, followed-up or newly diagnosed in pediatric gastroenterology unit, who had cirrhosis or non cirrhotic portal hypertension included to the study. Written informed consent obtained from the parents and/or patients. The subjects was grouped in three. The first group consisted of patients with cirrhosis (with or without portal hypertension). The second group consisted of patients with non-cirrhotic portal hypertension (developed due thrombosis of portal vein). The last group consisted of healthy volunteers.

2 ml of EDTA blood was taken from the patients and healty volunters. Samples will be tested for vWF and ADAMTS-13 levels and activities at the end of the study.

The clinical scoring methods, PELD, MELD and Child Pugh scores, treatments received by patients, data from endoscopic, radiological screening, and blood analysis of patients were recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cirrhosis or portal hypertension aged 3 months to 18 years.

Exclusion criteria

  • Being treated with fresh frozen plasma in the recent month.
  • Patients previously diagnosed with bleeding diathesis.
  • The patients who consumed vitamin K in the recent three weeks.
  • Patients previously diagnosed with another chronic disease (such as renal failure, heart failure etc).
  • Patients who suffer from acute or chronic infectious diseases.

Treatment and study plan

Primary outcomes

  1. Measuring ADAMTS-13 enzyme levels in collected EDTA bloods.

    Time frame: First day

    Measuring ADAMTS-13 antigen levels using commercial ELISA kits (IU/mL) in all groups.

  2. Measuring ADAMTS-13 activities in collected EDTA bloods.

    Time frame: First day

    Measuring ADAMTS-13 activities using commercial ELISA kits (as a percentage) in all groups.

  3. Measuring vWF antigen levels in collected EDTA bloods.

    Time frame: First day

    Measuring vWF antigen levels using immunoturbidimetric assay (as a percentage) in all groups.

  4. Measuring vWF activities in collected EDTA bloods.

    Time frame: First day

    Measuring vWF activities [von Willebrand factor ristocetin cofactor (vWF:RCo)] by the aggregation of platelets in the presence of ristocetin using immunoturbidimetric assay (as a percentage).

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Investigation of Changes in ADAMTS-13 and Von Willebrand Factor Levels and Activities in Children With Cirrhosis and/or Portal Hypertension

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2020
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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