HEMOCC Study. Hemostasis in Cirrhotic Children.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Child, Only; Esophageal and Gastric Varices

Treatments: Other: Collecting Clinical Data; Other: Collecting laboratory data

Study type: Interventional

Funder types: Other

Identifiers

NCT03244332

2013/06JUI/358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 4 months to 50 years old

Volunteers: No Healthy Volunteers

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,...)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Decompensated cirrhosis

Experimental group

Description:

Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.

Treatment:

Other: Collecting laboratory data

Other: Collecting Clinical Data

Compensated cirrhosis

Experimental group

Description:

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)

Treatment:

Other: Collecting laboratory data

Other: Collecting Clinical Data