Investigation of Changes in ADAMTS-13 and Von Willebrand Factor Levels and Activities in Children With Cirrhosis and/or Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Measuring ADAMTS-13 activities in collected EDTA bloods.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with cirrhosis or portal hypertension aged 3 months to 18 years.
排除标准
- •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.
结局指标
主要结局
Measuring ADAMTS-13 activities in collected EDTA bloods.
时间窗: 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.
时间窗: First day
Measuring ADAMTS-13 antigen levels using commercial ELISA kits (IU/mL) in all groups.
Measuring vWF antigen levels in collected EDTA bloods.
时间窗: First day
Measuring vWF antigen levels using immunoturbidimetric assay (as a percentage) in all groups.
Measuring vWF activities in collected EDTA bloods.
时间窗: 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).
次要结局
未报告次要终点
研究者
Ali Islek
Associate Professor
Ataturk University