An observational study in Cirrhosis, Liver, Frailty and Ascites, sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica. Recruiting at 1 site in Slovakia. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica · Observational
Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit
On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate.
After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution [FDR]) Mortality data are uploaded from the national registry of dead on regular basis
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Included are patients with liver cirrhosis and indication for hospital admission who are or are not candidates for liver transplant and have or do not have liver cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consenting adults admitted with liver cirrhosis; recorded/uploaded are demographic, clinical, laboratory and imaging data
Frequency and type of decompensation of liver cirrhosis
Registrations reflect cirrhosis prevalence; decompensation are acute, chronic, or acute-on-chronic
Time frame: "1 year"
Mortality
Record mortality in registered cirrhotics
Time frame: "1 year"
Mortality
Record mortality in registered cirrhotics
Time frame: 90-day
Mortality
Record mortality in registered cirrhotics
Time frame: 1 year
Frailty
Measurement of the liver frailty index
Time frame: On admission
Plan to share: Yes — Sharing by request primarily by investigators from other centres, editors of medical journals, authors of meta analyses, etc
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: On request, immediately, open ended
Access criteria: GDPR compliance Medical Journal Editorial office approved person Auditing authority Approved scientist
Data sharing details ↗ · www.fnspfdr.sk
No publications or documents are linked to this record.
Ran from Jul 2014 to primary completion in Feb 2021, 79 months.
Of 231 non-industry observational studies under Liver Cirrhosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 79 months is above that.
Counting every sponsor, half of 247 studies reached it within 47 months; a quarter within 18 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica