NCT03409263

Brief Summary

Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Mar 2018

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 Progress86%
Mar 2018Dec 2027

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

9.8 years

First QC Date

January 18, 2018

Last Update Submit

November 4, 2024

Conditions

Portal Hypertension

Keywords

CirrhosisAdvanced chronic liver diseaseAscitesVariceal hemorrhageTransjugular intrahepatic portosystemic shunt

Outcome Measures

Primary Outcomes (1)

  • Transplant-free survival

    Assessment of transplant-free survival after TIPS implantation

    0-10 years

Secondary Outcomes (4)

  • Assessment of portalhypertensive complications

    0-10 years

  • Assessment of hepatic encephalopathy

    0-10 years

  • Assessment of Patient Reported Quality of Life (SF36v2)

    0-10 years

  • Assessment of Patient Reported Quality of Life (CLDQ)

    0-10 years

Interventions

Observational studyOTHER

Not applicable (observational registry study)

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients or outpatients who are scheduled for TIPS implantation, or who have recently undergone TIPS implantation and are visiting outpatienc clinics for control visits/surveillance

You may qualify if:

  • Age 18-99 years
  • Portal hypertension
  • Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
  • Informed consent

You may not qualify if:

  • Retraction of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (collected during routine blood draws): chemistry, hematology, coagulation panel Ascites: WBC, PMN, protein Urine assessment: RBC, protein, sediment

MeSH Terms

Conditions

Hypertension, PortalFibrosisAscites

Interventions

Observation

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Thomas Reiberger, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Reiberger, MD

CONTACT

+43140400thomas.reiberger@meduniwien.ac.at

Lukas Hartl, MD

CONTACT

+43140400lukas.a.hartl@meduniwien.ac.at

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Univ. Prof. Priv.-Doz. Dr.

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

March 28, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Individual participant data may not be shared publicly due to local data safety regulations. Please contact the sponsor for more information.

Locations

AU(1)