NCT03244332

HEMOCC Study. Hemostasis in Cirrhotic Children.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 4 Months – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal and Gastric Varices
• Child, Only

Interventions

Type	Name	Description
OTHER	Collecting Clinical Data	Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)
OTHER	Collecting laboratory data	Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.

Timeline

• Start date: 2013-10-18
• Primary completion: 2017-07-15
• Completion: 2017-07-15
• First posted: 2017-08-09
• Last updated: 2017-08-09

Locations

1 site across 1 country: Belgium