Clinical trial NCT03244332: HEMOCC Study. Hemostasis in Cirrhotic Children.
Official title: HEMOCC Study Hemostasis in Cirrhotic Children : Assessment of Risk Factors of Spontaneous Bleeding From Oesophageal Varices in Cirrhotic Children Waiting for a Graft.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal and Gastric Varices
Child, Only
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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,...)

Primary outcomes:
measure: To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
timeFrame: over 2 year period
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Xavier Stephenne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonnet N, Paul J, Helleputte T, Veyckemans F, Pirotte T, Pregardien C, Eeckhoudt S, Hermans C, Detaille T, Clapuyt P, Menten R, Dumitriu D, Reding R, Scheers I, Varma S, Smets F, Sokal E, Stephenne X. Novel insights into the assessment of risk of upper gastrointestinal bleeding in decompensated cirrhotic children. Pediatr Transplant. 2019 Jun;23(4):e13390. doi: 10.1111/petr.13390. Epub 2019 Mar 19.