HEMOCC Study. Hemostasis in Cirrhotic Children. (HEMOCC)
Primary Purpose
Esophageal and Gastric Varices, Child, Only
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Collecting Clinical Data
Collecting laboratory data
Sponsored by
About this trial
This is an interventional prevention trial for Esophageal and Gastric Varices
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,…)
Sites / Locations
- Cliniques Universitaires Saint-Luc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Decompensated cirrhosis
Compensated cirrhosis
Arm Description
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)
Outcomes
Primary Outcome Measures
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
Secondary Outcome Measures
Full Information
NCT ID
NCT03244332
First Posted
July 27, 2017
Last Updated
August 8, 2017
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03244332
Brief Title
HEMOCC Study. Hemostasis in Cirrhotic Children.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 18, 2013 (Actual)
Primary Completion Date
July 15, 2017 (Actual)
Study Completion Date
July 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal and Gastric Varices, Child, Only
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decompensated cirrhosis
Arm Type
Experimental
Arm Description
Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation.
Arm Title
Compensated cirrhosis
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Collecting Clinical Data
Intervention Description
Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)
Intervention Type
Other
Intervention Name(s)
Collecting laboratory data
Intervention Description
Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.
Primary Outcome Measure Information:
Title
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
Time Frame
over 2 year period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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,…)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Stephenne, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no plan at this time
Citations:
PubMed Identifier
30888111
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.
Results Reference
derived
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HEMOCC Study. Hemostasis in Cirrhotic Children.
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