Investigation of Changes in ADAMTS-13 and Von Willebrand Factor Levels and Activities in Children With Cirrhosis and/or Portal Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Measuring ADAMTS-13 activities in collected EDTA bloods.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
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.
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.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Ali Islek
Associate Professor
Ataturk University