An observational study in Portal Hypertension, sponsored by Thomas Reiberger. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Thomas Reiberger · Observational
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.
Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.
375 studies on the registry are indexed under Hypertension, Portal; 114 are open to participants now.
This study's planned enrollment of 400 is above the median of 150 across 135 observational studies indexed under Hypertension, Portal.
Browse Hypertension, Portal studies →This is the only study on the registry with Thomas Reiberger as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
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.
Not applicable (observational registry study)
Transplant-free survival
Assessment of transplant-free survival after TIPS implantation
Time frame: 0-10 years
Assessment of portalhypertensive complications
Incidence of portalhypertensive complications
Time frame: 0-10 years
Assessment of hepatic encephalopathy
Incidence of hepatic encephalopathy
Time frame: 0-10 years
Assessment of Patient Reported Quality of Life (SF36v2)
Validated Questionnaire: SF36v2 pre TIPS and after TIPS. The SF36 consists of 36 items measuring 8 domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The mental (MCS) and physical (PCS) component summary scores, as the main read-outs of the SF-36 form, can be regarded as physiological ('normal') when the calculated score lies between 45 and 55, because the results are normalized to a normal "reference" population assigned 50 points. Scores below 45 define worse-than-average physical (PCS) or mental (MCS) health, while scores above 55 indicate better-than-average physical (PCS) or mental (MCS) health, when compared to a normal population.
Time frame: 0-10 years
Assessment of Patient Reported Quality of Life (CLDQ)
Validated Questionnaire CLDQ pre TIPS and after TIPS The CLDQ includes 29 items in the following domains: abdominal symptoms, fatigue, systemic symptoms, activity, emotional function and worry. The responses in the 29 CLDQ items, respectively, are recorded on scales ranging from in 1 ("none of the time") to 7 ("all of the time").
Time frame: 0-10 years
Plan to share: No — Individual participant data may not be shared publicly due to local data safety regulations. Please contact the sponsor for more information.
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