ITMO public health
Last update : 07/16/2014 | Version : 1 | ID : 8360
| General | |
| Identification | |
| Detailed name | Cohort on Acute Liver Failure without Identified Cause |
| Sign or acronym | HASI-PRO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Anatomy - Cytology Biology |
| Health determinants |
Nutrition |
| Others (details) | Acute Liver Failure |
| Keywords | Rare disease, liver function, indeterminate acute liver failure, liver transplantation, criteria for transplantation, antibodies, toxicology, survival., cause, etiology, genetics |
| Scientific investigator(s) (Contact) | |
| Name of the director | Duclos-Vallée |
| Surname | Jean-Charles |
| Address | Hôpital Paul Brousse - 12-14 avenue Paul Vaillant Couturier - 94800 Villejuif - France |
| Phone | +33 (0)1 45 59 33 36 |
| jean-charles.duclos-vallee@pbr.aphp.fr | |
| Unit | Centre Hépato-Biliaire |
| Organization | Hôpital Paul |
| Name of the director | Coilly |
| Surname | Audrey |
| Address | Hôpital Paul Brousse - 12-14 avenue Paul Vaillant Couturier - 94800 Villejuif - France |
| Phone | +33 (0)1 45 59 33 36 |
| audrey.coilly@pbr.aphp.fr | |
| Unit | Centre Hépato-Biliaire |
| Organization | Hôpital Paul |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | APHP |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre hépato-biliaire Paul Brousse |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Comprehensive (all patients presenting in the Centre hépato-biliaire Paul Brousse and matching the inclusion criteria). |
| Database objective | |
| Main objective | Acute liver failure predictive factors known and validated and the default for patients admitted in a context of acute liver failure without identified cause and includes liver transplantation. The identification of new prognostic criteria which is essential for better care and improved survival of patients admitted for acute liver failure. Principal objective: - To determine early prognostic factors of mortality in patients admitted for acute liver failure without identified cause. Secondary objectives: - Describe the evolution of acute liver failure without identified cause in 3 months. - Search posterior rare acute liver failure causes: genetic study (polymorphism of the genes encoding cytokeratins 8 and 18), detection of novel antibodies by serum proteome analysis, toxicological study by mass spectrometry. |
| Inclusion criteria | - Over the age of 18 - cytolysis and/or cholestasis WITH prothrombin time less than 50% or greater than 1.5 INR - signed informed consent by the patient or trusted person - without chronic underlying liver disease - cause of acute liver failure not identified at admission - non-participation in a therapeutic study may alter the patient's prognosis |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Centre Hépato-biliaire Paul Brousse, Villejuif, France. |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2013 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 100 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Biological data (detail) | DNA collection, urine and serum for future research into genetic and toxic factors. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Fluids (saliva, urine, amniotic fluid, …) DNA |
| Details of biobank content | DNA, urine, serum |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization |
| Procedures | |
| Data collection method | Systematic collection of clinical and biological data J0, J1, J2, J3, J5, J7, M1, M3 and during HT (data already collected as part of the treatment). Etiological research depth to M1. Blood and urine J0 for the formation of biological collections. Freezing of tissue for liver biopsy sample or a native liver sample in the case of HT. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | J0, J1, J2, J3, J5, J7, M1, M3 and during liver transplantation. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21465508 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24904954 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21465508 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/24904954 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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