NCT06781502

Brief Summary

ELECTRONIC ARCHIVE OF INTERNAL MEDICINE FOR THE TREATMENT OF SERIOUS ORGAN FAILURES AND LIVER TRANSPLANTATION

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
90mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Oct 2023Oct 2033

Study Start

First participant enrolled

October 21, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 17, 2025

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2033

Last Updated

January 17, 2025

Status Verified

October 1, 2024

Enrollment Period

10 years

First QC Date

December 3, 2024

Last Update Submit

January 13, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Epidemiological classification of Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine

    This indicator will evaluate the main diagnostic states and substates of patients with acute or chronic liver disease and/or liver transplantation, followed at the U.O. of Internal Medicine for serious organ failure and the Liver Transplant Program of the IRCCS AOUBO.

    10 years

  • Incidence of Complications in Chronic Liver Disease

    This measure aims to assess the incidence of complications associated with chronic liver disease in patients followed at the U.O. of Internal Medicine and the Liver Transplant Program of the IRCCS AOUBO.

    10 years

  • Hospitalization Rates

    This section analyzes the hospitalization rates of patients with acute and chronic liver diseases, highlighting the frequency of hospital stays.

    10 years

  • Number of Liver Transplantation Candidates Evaluated

    This measure tracks the number of patients evaluated for liver transplantation at the U.O. of Internal Medicine and the Liver Transplant Program of the IRCCS AOUBO

    10 years

  • Number of Liver Transplants Performed Annually

    This measure tracks the number of liver transplants performed annually at the U.O. of Internal Medicine and the Liver Transplant Program of the IRCCS AOUBO.

    10 years

Secondary Outcomes (2)

  • Description of Prescribed Treatments and Variations for Acute or Chronic Liver Disease and Liver Transplant Candidates at the U.O. of Internal Medicine

    10 years

  • Survival Rate Quantification

    10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients belonging to the U.O. will be enrolled. of the Liver Transplant Program of the IRCCS University Hospital of Bologna (Internal Medicine Unit for the treatment of serious organ failure, U.O. Hepatobiliary and Transplant Surgery, Program Abdominal surgery in end organ failure and in patients with organ transplant), in which a diagnosis of acute or chronic liver disease has been made or undergoing liver transplant, starting from 01/01/2013.

You may qualify if:

  • Diagnosis of acute or chronic liver disease or LT
  • Age ≥ 18 years
  • Obtaining informed consent

You may not qualify if:

  • no one

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS - Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giovanni Vitale, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Vitale, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 17, 2025

Study Start

October 21, 2023

Primary Completion (Estimated)

October 1, 2033

Study Completion (Estimated)

October 1, 2033

Last Updated

January 17, 2025

Record last verified: 2024-10

Locations