Esophageal and Gastric VaricesHEMOCCNCT03244332
HEMOCC Study. Hemostasis in Cirrhotic Children.
A study testing Collecting Clinical Data and Collecting laboratory data in people with Esophageal and Gastric Varices and Child, Only, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 4 months to 50 years
- Conditions the study is for
- Esophageal and Gastric Varices, Child, Only
- What is being tested?
- Collecting Clinical Data and Collecting laboratory data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Oct 2013to 15 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 months to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- No underlying disease which can alter hemostasis (hemophilia, sepsis…)
- No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,…)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Esophageal and Gastric Varices, Child, Only
- Being tested
- Collecting Clinical Data, Collecting laboratory data
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting Clinical DataOther
Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)
Collecting laboratory dataOther
Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Decompensated cirrhosis | Experimental | Children suffering from decompensated cirrhosis and needing an orthotopic liver transplantation. Receives: 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) Receives: Other: Collecting Clinical Data; Other: Collecting laboratory data |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
Measured: over 2 year period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start18 Oct 2013
- Primary completion15 Jul 2017
- Study completion15 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal and Gastric VaricesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Stephenne, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244332
- Sponsor's protocol ID
- 2013/06JUI/358
- Acronym
- HEMOCC
- Status last verified
- Jul 2017
- First submitted
- 27 Jul 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan at this time
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.
PubMed 30888111
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03244332
- Acronym / sponsor ID
- HEMOCC / 2013/06JUI/358
- Conditions
- Esophageal and Gastric Varices, Child, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 18 Oct 2013 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 15 Jul 2017 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Decompensated cirrhosis | Experimental | Other: Collecting Clinical Data, Other: Collecting laboratory dataChildren suffering from decompensated cirrhosis and needing an orthotopic liver transplantation. |
| Compensated cirrhosis | Experimental | Other: Collecting Clinical Data, Other: Collecting laboratory dataChildren 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) |
Who may qualify
- Ages
- 4 months to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- No underlying disease which can alter hemostasis (hemophilia, sepsis…)
- No medication which can alter hemostasis (aspirin, anti-inflammatory drugs,…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting Clinical DataClinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation) | Other | Compensated cirrhosis, Decompensated cirrhosis |
| Collecting laboratory dataLaboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis. | Other | Compensated cirrhosis, Decompensated cirrhosis |
Primary outcome
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions
Time frame: over 2 year period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Derived from this study: PubMed 30888111Bonnet 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.
- Individual participant dataSharing planned: Undecided. There is no plan at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Stephenne, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collecting Clinical Data and Collecting laboratory data in people with Esophageal and Gastric Varices and Child, Only, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate risk factors of spontaneous bleeding from oesophageal varices which are independant of liver functions (time frame: over 2 year period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244332, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.