HEMOCC Study. Hemostasis in Cirrhotic Children.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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HEMOCC Study Hemostasis in Cirrhotic Children : Assessment of Risk Factors of Spontaneous Bleeding From Oesophageal Varices in Cirrhotic Children Waiting for a Graft.

Conditions
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Esophageal and Gastric Varices, Child, Only

Intervention / Treatment
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* Other: Collecting Clinical Data
* Other: Collecting laboratory data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: No underlying disease which can alter hemostasis (hemophilia, sepsis…) No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,…)

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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/haemorrhaegic disorder will be excluded.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decompensated cirrhosis<br>Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation. | Other: Collecting Clinical Data<br>* Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)<br>Other: Collecting laboratory data<br>* Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.<br>|
| Experimental: Compensated cirrhosis<br>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) | Other: Collecting Clinical Data<br>* Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)<br>Other: Collecting laboratory data<br>* Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions |  | over 2 year period |