HEMOCC Study. Hemostasis in Cirrhotic Children.

Child, Only Clinical Trial

— HEMOCC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244332
• Other study ID #: 2013/06JUI/358
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: August 8, 2017
• Start date: October 18, 2013
• Est. completion date: July 15, 2017

Study information

• Verified date: July 2017
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 15, 2017
• Est. primary completion date: July 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 50 Years

Eligibility

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,…)

Related Conditions & MeSH terms

• Child, Only
• Esophageal and Gastric Varices

Intervention

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

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions		over 2 year period