An observational study in Coagulation Disorder and Cirrhosis, Liver, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Ataturk University · Observational
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.
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.
515 studies on the registry are indexed under Hemostatic Disorders; 72 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 233 observational studies indexed under Hemostatic Disorders.
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Patients with cirrhosis and/or portal hypertension who were treated in Pediatric Gastroenterology Department of Ataturk University Hospital included to the study.
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Exclusion Criteria:
Patients who diagnosed as cirrhosis. 2 ml EDTA blood sample was taken from patients during their routine controls or at the time of diagnosis. Samples will be tested for ADAMTS-13 and vWF levels and activity at the end of study.
Patients who diagnosed as extrahepatic portal hypertension (due to portal vein thrombosis). 2 ml EDTA blood sample was taken from patients during their routine controls or at the time of diagnosis. Samples will be tested for ADAMTS-13 and vWF levels and activity at the end of study.
Healthy volunteers, who admitted to our hospital for any complaints, but was not determined any organic disease. 2 ml EDTA blood sample was taken from healthy volunteers, during their hospital admition. Samples will be tested for ADAMTS-13 and vWF levels and activity at the end of study.
Measuring ADAMTS-13 enzyme levels in collected EDTA bloods.
Measuring ADAMTS-13 antigen levels using commercial ELISA kits (IU/mL) in all groups.
Time frame: First day
Measuring ADAMTS-13 activities in collected EDTA bloods.
Measuring ADAMTS-13 activities using commercial ELISA kits (as a percentage) in all groups.
Time frame: First day
Measuring vWF antigen levels in collected EDTA bloods.
Measuring vWF antigen levels using immunoturbidimetric assay (as a percentage) in all groups.
Time frame: First day
Measuring vWF activities in collected EDTA bloods.
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).
Time frame: First day
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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