Fulminating Hepatic FailureDEVINHEFNCT04658407
Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Public Hospitals of Paris
An observational study of Fulminating Hepatic Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Fulminating Hepatic Failure
- How many people
- 18,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 Dec 2021
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with Severe liver failure or toxicants that may cause a liver failure
Who may be able to join
- Age > 15
- Severe liver failure or toxicants that may cause a liver failure Or
- (PR<50% or INR >1.5) And ALT >250
Who cannot join
- Patients with underlying chronic liver disease
- Patients with the conditions given by this following ICD (International Classification of Diseases) : B18 - E831 - K70 - K715 - K717 - K730- K731 - K732 - 738 - K74 - K753 - K758 - K760 - K761
Trial locations and contacts
1 site in 1 country.
France1 site
Paul Brousse Hospital
Villejuif, 94804
Philippe ICHAI, MD, PhD, +33 (1) 45 59 64 35, philippe.ichai@aphp.fr
Philippe ICAHI, MD, PhD
About this study
Official title: Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Hospitals of the Assistance Publique - Hôpitaux de Paris (APHP)
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.
Read the detailed description
Severe, fulminating acute liver failure is a rare but serious disease. The overall prognosis has improved in recent years thanks to advances in medical management and liver transplantation.
However, the epidemiology of this disease in France, the survival with or without liver transplantation of these patients and the factors that can influence this survival are not well known.
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris (APHP).
The data will come from the APHP Health Data Warehouse
- Conditions
- Fulminating Hepatic Failure
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all patients diagnosed with a severe hepatic failure | Retrospective cohort using only data already entered in the Health data warehouse of the APHP (Public Paris Hospital) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe and fulminating acute hepatic failure within AP-HP hospitals
Patient status 1 month after diagnosis of this episode (alive or dead with or without transplantation)
Measured: 1 month from the diagnosis of this episode
Secondary outcomes (4)
Epidemiology of Severe and fulminating acute hepatic failure
Sex Ratio M / F and cause of liver failure
Measured: Baseline
Cause of death
Cause of death
Measured: From date of inclusion until the date of death from any cause, assessed up to 9 years
Analysis of Clinical Pathway
Identification of the different services visited
Measured: up to 1month after the diagnosis of this episode
Reasons for new hospitalizations with an admission date within 6 months after the diagnosis this episode
Identification by the usual code of the new hospitalization, consecutive to the episode
Measured: within 6 months after the diagnosis this episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start1 Apr 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fulminating Hepatic FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658407
- Sponsor's protocol ID
- AP-HP200240
- Acronym
- DEVINHEF
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Outcome With Severe or Fulminant Hepatic Insufficiency, Hospitalized in the Hospitals of the Assistance Publique - Hôpitaux de Paris (APHP)
- ClinicalTrials.gov ID
- NCT04658407
- Acronym / sponsor ID
- DEVINHEF / AP-HP200240
- Conditions
- Fulminating Hepatic Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Dec 2020 (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.
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris.
Detailed description
Severe, fulminating acute liver failure is a rare but serious disease. The overall prognosis has improved in recent years thanks to advances in medical management and liver transplantation.
However, the epidemiology of this disease in France, the survival with or without liver transplantation of these patients and the factors that can influence this survival are not well known.
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe, fulminating acute liver failure in the public hospitals of paris (APHP).
The data will come from the APHP Health Data Warehouse
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients diagnosed with a severe hepatic failure | – | –Retrospective cohort using only data already entered in the Health data warehouse of the APHP (Public Paris Hospital) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with Severe liver failure or toxicants that may cause a liver failure
Key inclusion criteria (3 listed)
- Age > 15
- Severe liver failure or toxicants that may cause a liver failure Or
- (PR<50% or INR >1.5) And ALT >250
Key exclusion criteria (2 listed)
- Patients with underlying chronic liver disease
- Patients with the conditions given by this following ICD (International Classification of Diseases) : B18 - E831 - K70 - K715 - K717 - K730- K731 - K732 - 738 - K74 - K753 - K758 - K760 - K761
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe and fulminating acute hepatic failure within AP-HP hospitals
Time frame: 1 month from the diagnosis of this episode
Patient status 1 month after diagnosis of this episode (alive or dead with or without transplantation)
4 secondary outcomes
Epidemiology of Severe and fulminating acute hepatic failure
Time frame: Baseline
Cause of death
Time frame: From date of inclusion until the date of death from any cause, assessed up to 9 years
Analysis of Clinical Pathway
Time frame: up to 1month after the diagnosis of this episode
Reasons for new hospitalizations with an admission date within 6 months after the diagnosis this episode
Time frame: within 6 months after the diagnosis this episode
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Fulminating Hepatic Failure
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Risk Factors and Outcomes of Hepatitis A in Children
Hepatitis A, Acute Hepatitis
Not yet recruitingObservational study
Prevalence and Prognosis of Drug-Induced Liver Injury
Drug-Induced Liver Injury
Recruiting
Role of N-Acetylcysteine in Non-Acetaminophen-Induced Liver Failure
Acute Liver Failure
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fulminating Hepatic Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 1 Mar 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe ICHAI (01 45 59 64 35, philippe.ichai@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main objective is to determine the medical fate (transplanted or not and living or deceased), of patients with Severe and fulminating acute hepatic failure within AP-HP hospitals (time frame: 1 month from the diagnosis of this episode). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2021.