HEMOCC Study. Hemostasis in Cirrhotic Children. (HEMOCC)

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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal and Gastric Varices; Child, Only
• Intervention / Treatment: Other: Collecting Clinical Data; Other: Collecting laboratory data

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Decompensated cirrhosis; Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.	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.
Experimental: Compensated cirrhosis; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions	over 2 year period

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Xavier Stephenne, MD, PhD, Cliniques Universitaires Saint-Luc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2013
• Primary Completion (Actual): July 15, 2017
• Study Completion (Actual): July 15, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2017
• Last Update Submitted That Met QC Criteria: August 8, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices
• Other Study ID Numbers: 2013/06JUI/358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is no plan at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No