HEMOCC Study Hemostasis in Cirrhotic Children : Assessment of Risk Factors of Spontaneous Bleeding From Oesophageal Varices in Cirrhotic Children Waiting for a Graft.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
研究概览
简要总结
Prospective investigations into the role of hemostatic factors in the risk of variceal bleeding among children with chronic liver disease (thromboelastometry e.g) is still required. A better understanding of these factors would permit better risk stratification and targeted prophylaxis or therapy.
详细描述
The investigators aim to start a prospective and observational study over a 2 years period.
First, the investigators will identify all children suffering from cirrhosis irrespective of underlying etiology and/or portal hypertension coming into the pediatric hepatogastroenterology unit at Saint-Luc University Clinics. Any patient with a congenital or acquired thrombophilia/haemorrhagic disorder will be excluded. The investigators expect to include 20 to 30 children in the study.
The investigators will meet the parents to give them explanations about this study and its implications. Then the investigators will get the free and informed consent about the participation to this clinical study. Parents are obviously free to refuse to take part in this clinical study and to retire from it at any moment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation
- •Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g)
- •Each patient will have a comprehensive assessment of portal hypertension (abdominal US-Doppler and upper gastrointestinal endoscopy) and hemostasis
排除标准
- •No underlying disease which can alter hemostasis (hemophilia, sepsis...)
- •No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,...)
研究组 & 干预措施
Decompensated cirrhosis
Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.
干预措施: Collecting Clinical Data (Other)
Decompensated cirrhosis
Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.
干预措施: Collecting laboratory data (Other)
Compensated cirrhosis
Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g)
干预措施: Collecting Clinical Data (Other)
Compensated cirrhosis
Children suffering from a compensated cirrhosis (compensated cirrhosis with kasai surgery in biliary atresia patients e.g) or from portal hypertension without cirrhosis (portal vein thrombosis e.g)
干预措施: Collecting laboratory data (Other)
结局指标
主要结局
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
时间窗: over 2 year period
次要结局
未报告次要终点