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HEMOCC Study. Hemostasis in Cirrhotic Children. (HEMOCC)

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ClinicalTrials.gov Identifier: NCT03244332
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Esophageal and Gastric Varices Child, Only Other: Collecting Clinical Data Other: Collecting laboratory data Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.

Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : October 18, 2013
Actual Primary Completion Date : July 15, 2017
Actual Study Completion Date : July 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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.




Primary Outcome Measures :
  1. To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions [ Time Frame: over 2 year period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244332


Locations
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Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Xavier Stephenne, MD, PhD Cliniques universitaires Saint-Luc

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03244332     History of Changes
Other Study ID Numbers: 2013/06JUI/358
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Hemostatics
Coagulants