NCT04393519

Brief Summary

Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
54mo left

Started May 2020

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 Progress59%
May 2020Dec 2030

First Submitted

Initial submission to the registry

May 12, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

10.6 years

First QC Date

May 12, 2020

Last Update Submit

October 4, 2021

Conditions

Portal Hypertension

Keywords

transjugular intrahepatic portosystemic shunt (TIPS)non-invasive assessmentsTransthoracic echocardiography (TTE) with Speckle-trackingComputer tomography scan (CT-scan)Magnetic resonance imaging (MRI)Circulating biomarkersElectroencephalography (EEG)Elastography

Outcome Measures

Primary Outcomes (1)

  • Survival

    death, liver transplantation

    up to 10 years

Secondary Outcomes (9)

  • Ascites

    up to 10 years

  • Hepatic Encephalopathy (HE)

    up to 10 years

  • Variceal Bleeding

    up to 10 years

  • Liver Failure

    up to 10 years

  • Acute-on-Chronic Liver Failure (ACLF)

    up to 10 years

  • +4 more secondary outcomes

Study Arms (1)

Prospective

Prospective cohort that received TIPS from 05/12/2020 onwards

Device: TIPS procedure

Interventions

TIPS procedureDEVICE

Implantation of TIPS for portal hypertension

Prospective

Eligibility Criteria

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

All patients receiving TIPS according to guidelines

You may qualify if:

  • Insertion of TIPS according to guidelines

You may not qualify if:

  • Contraindication for TIPS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bonn

Bonn, Germany

RECRUITING

Related Publications (1)

  • Heger LA, Chang J, Rohrer C, Reincke M, Eyth A, Sturm L, Schultheiss M, Maier A, Meyer C, Jansen C, Graf K, Ozturk C, Schneider F, Trebicka J, Westermann D, Thimme R, Grundmann S, Praktiknjo M, Bettinger D. Right Ventricular Contractility Predicts Clearance of Ascites After Transjugular Intrahepatic Portosystemic Shunt. Liver Int. 2025 Dec;45(12):e70422. doi: 10.1111/liv.70422.

    PMID: 41204773DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, stool, ascites, DNA, PBMC, Buffi coat

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Michael Praktiknjo, MD

    University of Bonn

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Praktiknjo, MD

CONTACT

+49(0)228-287 15770michael.praktiknjo@ukbonn.de

Johannes Chang, MD

CONTACT

+49(0)228-287 15770johannes.chang@ukbonn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 19, 2020

Study Start

May 12, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

October 5, 2021

Record last verified: 2021-10

Locations

DE(1)