HEMOCC Study. Hemostasis in Cirrhotic Children.

Not Applicable

Completed

• Conditions: Esophageal and Gastric Varices; Child, Only
• Interventions: Other: Collecting Clinical Data; Other: Collecting laboratory data

• Registration Number: NCT03244332
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10-18
• Status Verified: 2017-07
• Primary Completion: 2017-07-15
• Study Completion: 2017-07-15
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-08
• Last Update Submitted: 2017-08-08
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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,...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compensated cirrhosis	Collecting laboratory data	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)
Compensated cirrhosis	Collecting Clinical Data	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)
Decompensated cirrhosis	Collecting Clinical Data	Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.
Decompensated cirrhosis	Collecting laboratory data	Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.

Primary Outcome Measures

Name	Time	Method
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions	over 2 year period

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium