HEMOCC Study. Hemostasis in Cirrhotic Children.

NCT03244332 | Completed

• 1 other identifier: 2013/06JUI/358
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal and Gastric Varices; Child, Only

Outcome Measures

Primary Outcomes (1)

• To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions

  over 2 year period

Study Arms (2)

Decompensated cirrhosis

EXPERIMENTAL

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

Other: Collecting Clinical Data; Other: Collecting laboratory data

Compensated cirrhosis

EXPERIMENTAL

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)

Other: Collecting Clinical Data; Other: Collecting laboratory data

Interventions

Collecting Clinical Data OTHER

Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)

Compensated cirrhosis; Decompensated cirrhosis

Collecting laboratory data OTHER

Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.

Compensated cirrhosis; Decompensated cirrhosis

Eligibility Criteria

• Age: 4 Months - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• No underlying disease which can alter hemostasis (hemophilia, sepsis…)
• No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,…)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 30888111 DERIVED

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Study Officials

• Xavier Stephenne, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 9, 2017
• Study Start: October 18, 2013
• Primary Completion: July 15, 2017
• Study Completion: July 15, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-07

Locations

BE (1)