NCT03459378

Brief Summary

This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after TIPS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 26, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

February 26, 2018

Last Update Submit

May 14, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • transplantation free survival

    Survival without liver Transplantation in days

    from date of TIPS until the event, up to 4 years

Secondary Outcomes (2)

  • occurrence of hepatic encephalopathy

    from date of TIPS until the event, up to 4 years

  • occurrence of ascites

    from date of TIPS until the event, up to 4 years

Interventions

retrospective data examination, there are no study related interventions

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017

You may qualify if:

  • every person at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017

You may not qualify if:

  • age under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

Related Publications (1)

  • Furschuss L, Rainer F, Effenberger M, Niederreiter M, Portugaller RH, Horvath A, Fickert P, Stadlbauer V. A novel score predicts mortality after transjugular intrahepatic portosystemic shunt: MOTS - Modified TIPS Score. Liver Int. 2022 Aug;42(8):1849-1860. doi: 10.1111/liv.15236. Epub 2022 Apr 1.

MeSH Terms

Conditions

Hypertension, PortalLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 8, 2018

Study Start

March 23, 2018

Primary Completion

March 1, 2019

Study Completion

May 14, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations