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HRS-AKI Treatment With TIPS in Patients With Cirrhosis (Liver-HERO)

Primary Purpose

Cirrhosis, Liver, Hepatorenal Syndrome, Acute Kidney Injury

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TIPS
Standard of Care
Sponsored by
Jena University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis, Liver focused on measuring Ascites, Acute Kidney Injury, Cirrhosis, Hepatorenal Syndrome, TIPS, transjugular intrahepatic portosystemic shunt, Terlipressin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests
  2. Clinically evident ascites due to portal hypertension (SAAG > 1.1 g/dL)
  3. HRS-AKI stages 2 or 3
  4. Planned vasoactive treatment for the management of HRS, as defined by the administration of terlipressin + albumin
  5. Age: ≥ 18 to ≤ 75 years old at the time of consent
  6. ECOG < 4 prior to hospital admission
  7. Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form.
  8. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses). A contraceptive method with a pearl index below 1% is assumed to be effective.

Exclusion Criteria:

  1. Patients with signs of intrinsic renal disease as defined by proteinuria (> 500 mg per day), microhematuria (> 50 RBC per high power field) or signs of chronic renal disease on ultrasound.
  2. Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or iodinated contrast medium) in the previous 72 hours before AKI diagnosis
  3. Improvement of renal function after 2 days of diuretic removal and plasma volume expansion with albumin 1 gr/kg
  4. Uncontrolled shock
  5. Patients with uncontrolled infection (defined by a 20 % increase in inflammatory parameters (CRP, leucocytes or insufficient decrease of PMN in ascitic fluid < 25 % from baseline in the case of a SBP) despite 48 hours of antibiotic treatment.
  6. Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (ischemic cardiomyopathy, hypertensive cardiomyopathy, etc.)
  7. Patients with contraindications to TIPS placement (Bilirubin > 5 mg/dL, recurrent hepatic encephalopathy)
  8. Patients with cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis
  9. Patients with clinically significant cardiac disease (NYHA ≥ II)
  10. Patients with diastolic dysfunction grade 3.
  11. Patients with a reduced systolic function with an ejection fraction ≤ 50 %
  12. Patients with an acute variceal bleeding at the time of screening who have indication for pre-emptive TIPS and/or terlipressin.
  13. Patients with refractory ascites as defined by the International Ascites Club (< 800 gr weight loss over 4 days in patients on low salt diet and high dose diuretics (spironolactone 400 mg /day and furosemide * 160 mg /day), or lower dose of diuretics with complications secondary to the use of diuretics such as hyponatremia, renal failure, hepatic encephalopathy. *equivalent dose of torasemide 40 mg/day
  14. Patients with hepatocellular carcinoma outside of the Milan criteria
  15. Patients with hepatocellular carcinoma within the Milan criteria in whom the tumor is located in the puncture tract.
  16. Patients with benign liver tumors (except regenerative nodules) which are located in the puncture tract.
  17. Patients with other comorbidities that lead to an estimated life expectancy under 1 year.
  18. The subject is currently enrolled in another investigational device or drug trial.
  19. Patients with pregnancy or lactation

Sites / Locations

  • University Hospital RWTH AachenRecruiting
  • University Hospital Dresden, Medical Clinic I, GastroenterologyRecruiting
  • University Hospital Freiburg
  • University Hospital HalleRecruiting
  • University Hospital Hamburg-Eppendorf
  • Medical University Hannover
  • Jena University Hospital, Clinic for Inner Medicine IVRecruiting
  • University Hospital Leipzig
  • RKH Clinic LudwigsburgRecruiting
  • Ludwig-Maximilians-University, Klinikum GroßhadernRecruiting
  • University Hospital Münster, Medical Clinic B

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS group

Control group

Arm Description

TIPS implant (transjugular intrahepatic portosystemic shunt)

Standard medication therapy with terlipressin and albumin

Outcomes

Primary Outcome Measures

12 month Liver transplant-free survival
12 month Liver transplant-free survival

Secondary Outcome Measures

3-month liver transplant free survival
3-month liver transplant free survival
Number of patient which develop an indication for TIPS placement (variceal bleeding or refractory ascites) or TIPS revision (variceal bleeding or development of ascites) during follow-up
Number of patient which develop an indication for TIPS placement according to clinical guidelines (such as variceal bleeding or refractory ascites) in the control group or indication for a TIPS revision (variceal bleeding, development of ascites) in the intervention group will be assessed during the 12 months follow-up
Development of further decompensation of HRS-AKI during follow-up
Development of further decompensation as defined in the Baveno VII Consensus Workshop (e.g. overt hepatic encephalopathy, refractory or recurrent ascites, dilutional hyponatremia, new AKI-HRS, variceal bleeding) during follow-up
Reversal of HRS-AKI-AKI 3 MFU
Reversal of HRS-AKI-AKI at 3 months (vs. baseline), defined as return of serum creatinine level within 0.3 mg/dl (26 mmol/L).
Reversal of HRS-AKI-AKI 12 MFU
Reversal of HRS-AKI-AKI at 12 months (vs. baseline), defined as return of serum creatinine level within 0.3 mg/dl (26 mmol/L).
Partial response to treatment 3 MFU
Partial response to treatment at 3 months (vs. baseline) defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 mmol/L) above the baseline value.
Partial response to treatment 12 MFU
Partial response to treatment at 12 months (vs. baseline) defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 mmol/L) above the baseline value.
In-hospital survival
In-hospital survival of the patients (patients are hospitalized for diagnosis of HRS-AKI and start of treatment - due to poor diagnosis, patients may die during hospital stay)
28-day survival
28-day survival
90-day survival
90-day survival
Length of in-hospital-stay
Length of in-hospital-stay of the patients (patients are hospitalized for diagnosis of HRS-AKI and start of treatment)
Changes in HrQoL as measured by SF36 3 MFU
Relative changes in Health-related Quality of Life as measured by SF36 at 3 months (vs. baseline)
Changes in HrQoL as measured by SF36 12 MFU
Relative changes in Health-related Quality of Life as measured by SF36 at 12 months (vs. baseline)
Changes in HrQoL as measured by CLDQ 3 MFU
Relative changes in Health-related Quality of Life as measured by CLDQ (Chronic Liver Disease Questionnaire) at 3 months (vs. baseline)
Changes in HrQoL as measured by CLDQ 12 MFU
Relative changes in Health-related Quality of Life as measured by CLDQ (Chronic Liver Disease Questionnaire) at 12 months (vs. baseline)
Need for renal replacement therapy
Need for renal replacement therapy within Follow-up
recurrence of HRS-AKI after treatment at 3 months
recurrence of HRS-AKI after treatment at 3 months
recurrence of HRS-AKI after treatment at 12 months
recurrence of HRS-AKI after treatment at 12 months
Safety Assessment
Number of AEs and SAEs in each group with special attention on the development of acute on chronic liver failure and signs of heart failure.

Full Information

First Posted
April 1, 2022
Last Updated
June 27, 2023
Sponsor
Jena University Hospital
Collaborators
German Research Foundation, Center for Clinical Studies, Jena University Hospital, KKS Halle, University Hospital Halle (Saale)
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1. Study Identification

Unique Protocol Identification Number
NCT05346393
Brief Title
HRS-AKI Treatment With TIPS in Patients With Cirrhosis
Acronym
Liver-HERO
Official Title
Hepatorenal Syndrome-acute Kidney Injury (HRS-AKI) Treatment With Transjugular Intrahepatic Portosystemic Shunt in Patients With Cirrhosis. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jena University Hospital
Collaborators
German Research Foundation, Center for Clinical Studies, Jena University Hospital, KKS Halle, University Hospital Halle (Saale)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study compares the effectiveness and safety of TIPS implantation in patients with HRS-AKI (stage 2 and 3) and liver cirrhosis with standard therapy (drug therapy with terlipressin + albumin).
Detailed Description
Cirrhosis is a major cause of global health burden worldwide. Acute kidney injury (AKI) occurs in 20% of hospitalized patients with cirrhosis. Acute kidney injury is a relatively new definition of renal failure which takes into account the dynamic changes in serum creatinine. Among the causes of AKI, hepatorenal syndrome-AKI has the worst prognosis. HRS-AKI is an acute condition which occurs in patients with ascites, mainly refractory ascites. HRS-AKI includes the traditional hepatorenal syndrome type 1, which was defined by a serum creatinine cutoff and which has an ominous prognosis when left untreated, nevertheless HRS-AKI also includes milder forms of renal failure. The standard treatment of HRS-AKI is with the infusion of albumin and terlipressin. Although this treatment improves renal function, patients remain at risk for new episodes of HRS-AKI and liver transplantation should be considered. Nevertheless, this optimal solution is only a reality for a privileged few given the shortage of organs and the common presence of contraindications. Development of HRS-AKI is caused by increased pressure in the portal vein (the vein which brings the blood from the intestines to the liver), among other factors. Increased pressure in the portal vein, also called portal hypertension, is one of the main pathophysiological mechanisms that lead to the different complications of cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an interventional radiological procedure which reduces the pressure in the portal vein by creating a short-cut between the portal vein and the hepatic vein, the vein which brings the blood from the liver towards the heart. TIPS placement has become the mainstay of treatment of some complications of cirrhosis, namely variceal bleeding and refractory ascites. Although rationally plausible, the use of TIPS in HRS-AKI has not been evaluated in the context of randomized controlled trials. Indirect data suggest that it could be helpful, since patients who become TIPS have an improvement in renal hemodynamics and renal function as well as less episodes of HRS-AKI in the follow-up. On the other hand, traditional HRS type 1 can be associated to liver failure and cardiac alterations which contraindicate TIPS placement. HRS-AKI includes not only traditional HRS type 1, but also milder forms of the disease, so that it is reasonable to consider that TIPS placement may have a role in this condition. This study is a multicenter (9 centers), prospective, randomized controlled trial which evaluates use of TIPS in patients with HRS-AKI (stage 2 and 3) versus standard of care (albumin and terlipressin). Patients with cirrhosis and HRS-AKI who fulfill the inclusion criteria and do not have any exclusion criteria will be randomized to standard of care or standard of care and TIPS. Patients will be followed for a minimum of 12 months until the end of the trial. The main end-point is to compare the survival at the end of follow-up among the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver, Hepatorenal Syndrome, Acute Kidney Injury, Ascites Hepatic
Keywords
Ascites, Acute Kidney Injury, Cirrhosis, Hepatorenal Syndrome, TIPS, transjugular intrahepatic portosystemic shunt, Terlipressin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment 1:1-randomization, parallel design, stratified by center and AKI stage.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIPS group
Arm Type
Experimental
Arm Description
TIPS implant (transjugular intrahepatic portosystemic shunt)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard medication therapy with terlipressin and albumin
Intervention Type
Procedure
Intervention Name(s)
TIPS
Intervention Description
A transjugular intrahepatic portosystemic shunt (TIPS) is implanted into the cirrhotic liver
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Terlipressin + Albumin
Intervention Description
Administration of Terlipressin and Albumin according to Standard of Care
Primary Outcome Measure Information:
Title
12 month Liver transplant-free survival
Description
12 month Liver transplant-free survival
Time Frame
12 months after Baseline
Secondary Outcome Measure Information:
Title
3-month liver transplant free survival
Description
3-month liver transplant free survival
Time Frame
3 months after Baseline
Title
Number of patient which develop an indication for TIPS placement (variceal bleeding or refractory ascites) or TIPS revision (variceal bleeding or development of ascites) during follow-up
Description
Number of patient which develop an indication for TIPS placement according to clinical guidelines (such as variceal bleeding or refractory ascites) in the control group or indication for a TIPS revision (variceal bleeding, development of ascites) in the intervention group will be assessed during the 12 months follow-up
Time Frame
within 12 months after Baseline
Title
Development of further decompensation of HRS-AKI during follow-up
Description
Development of further decompensation as defined in the Baveno VII Consensus Workshop (e.g. overt hepatic encephalopathy, refractory or recurrent ascites, dilutional hyponatremia, new AKI-HRS, variceal bleeding) during follow-up
Time Frame
within 12 months after Baseline
Title
Reversal of HRS-AKI-AKI 3 MFU
Description
Reversal of HRS-AKI-AKI at 3 months (vs. baseline), defined as return of serum creatinine level within 0.3 mg/dl (26 mmol/L).
Time Frame
3 months after Baseline
Title
Reversal of HRS-AKI-AKI 12 MFU
Description
Reversal of HRS-AKI-AKI at 12 months (vs. baseline), defined as return of serum creatinine level within 0.3 mg/dl (26 mmol/L).
Time Frame
12 months after Baseline
Title
Partial response to treatment 3 MFU
Description
Partial response to treatment at 3 months (vs. baseline) defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 mmol/L) above the baseline value.
Time Frame
3 months after Baseline
Title
Partial response to treatment 12 MFU
Description
Partial response to treatment at 12 months (vs. baseline) defined as reduction of at least one AKI stage with decrease of serum creatinine to ≥ 0.3 mg/dl (26 mmol/L) above the baseline value.
Time Frame
12 months after Baseline
Title
In-hospital survival
Description
In-hospital survival of the patients (patients are hospitalized for diagnosis of HRS-AKI and start of treatment - due to poor diagnosis, patients may die during hospital stay)
Time Frame
baseline until 12 months
Title
28-day survival
Description
28-day survival
Time Frame
baseline until day 28 after baseline
Title
90-day survival
Description
90-day survival
Time Frame
baseline until day 90 after baseline
Title
Length of in-hospital-stay
Description
Length of in-hospital-stay of the patients (patients are hospitalized for diagnosis of HRS-AKI and start of treatment)
Time Frame
baseline until 12 months
Title
Changes in HrQoL as measured by SF36 3 MFU
Description
Relative changes in Health-related Quality of Life as measured by SF36 at 3 months (vs. baseline)
Time Frame
3 months after Baseline
Title
Changes in HrQoL as measured by SF36 12 MFU
Description
Relative changes in Health-related Quality of Life as measured by SF36 at 12 months (vs. baseline)
Time Frame
12 months after Baseline
Title
Changes in HrQoL as measured by CLDQ 3 MFU
Description
Relative changes in Health-related Quality of Life as measured by CLDQ (Chronic Liver Disease Questionnaire) at 3 months (vs. baseline)
Time Frame
3 months after Baseline
Title
Changes in HrQoL as measured by CLDQ 12 MFU
Description
Relative changes in Health-related Quality of Life as measured by CLDQ (Chronic Liver Disease Questionnaire) at 12 months (vs. baseline)
Time Frame
12 months after Baseline
Title
Need for renal replacement therapy
Description
Need for renal replacement therapy within Follow-up
Time Frame
12 months after Baseline
Title
recurrence of HRS-AKI after treatment at 3 months
Description
recurrence of HRS-AKI after treatment at 3 months
Time Frame
3 months after Baseline
Title
recurrence of HRS-AKI after treatment at 12 months
Description
recurrence of HRS-AKI after treatment at 12 months
Time Frame
12 months after Baseline
Title
Safety Assessment
Description
Number of AEs and SAEs in each group with special attention on the development of acute on chronic liver failure and signs of heart failure.
Time Frame
12 months after Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with cirrhosis confirmed by histology or liver stiffness or with unequivocal signs in ultrasound, endoscopy and/or blood tests Clinically evident ascites due to portal hypertension (SAAG > 11 g/L) HRS-AKI stages 2 or 3 Planned vasoactive treatment for the management of HRS, as defined by the administration of terlipressin + albumin Age: ≥ 18 to ≤ 75 years old at the time of consent ECOG < 4 prior to hospital admission Subject has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Ethics Committee (EC) approved consent form. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses). A contraceptive method with a pearl index below 1% is assumed to be effective. Exclusion Criteria: Patients with signs of intrinsic renal disease as defined by proteinuria (> 500 mg per day), microhematuria (> 50 RBC per high power field or > 200 erythrocytes per µl) or signs of chronic renal disease on ultrasound. Recent or current use of nephrotoxic drugs (NSAIDS, Aminoglycosides or iodinated contrast medium) in the previous 72 hours before AKI diagnosis Improvement of renal function after 2 days of diuretic removal and plasma volume expansion with albumin 1 gr/kg Uncontrolled shock within the last 48 hours prior to randomization Patients with uncontrolled infection (defined by a 20 % increase in inflam-matory parameters (CRP, leucocytes or insufficient decrease of PMN in ascitic fluid < 25 % from baseline in the case of a SBP) despite 48 hours of antibiotic treatment. Patients with cardiac cirrhosis as defined by the development of cirrhosis in a patient with chronic heart failure due to a primary cardiac disease (is-chemic cardiomyopathy, hypertensive cardiomyopathy, etc.) Patients with contraindications to TIPS placement (e.g. Bilirubin > 85.5 µmol/L (≙ 5 mg/dL), recurrent hepatic encephalopathy) Patients with cavernous portal vein thrombosis, splenic vein thrombosis or mesenteric vein thrombosis Patients with clinically significant cardiac disease (NYHA ≥ II) Patients with diastolic dysfunction grade 3. Patients with a reduced systolic function with an ejection fraction ≤ 50 % Patients with ACLF grade 3 Patients with creatinine value > 442 µmol/L (≙ 5 mg/dL) Patients with an acute variceal bleeding at the time of screening who have indication for pre-emptive TIPS and/or terlipressin. Patients with refractory ascites as defined by the International Ascites Club (< 800 gr weight loss over 4 days in patients on low salt diet and high dose diuretics (spironolactone 400 mg /day and furosemide * 160 mg /day), or lower dose of diuretics with complications secondary to the use of diuretics such as hyponatremia, renal failure, hepatic encephalopathy. *equivalent dose of torasemide 40 mg/day Patients with hepatocellular carcinoma outside of the Milan criteria Patients with hepatocellular carcinoma within the Milan criteria in whom the tumor is located in the puncture tract. Patients with benign liver tumors (except regenerative nodules) which are located in the puncture tract. Patients who already have a TIPS placed Patients who already had a liver transplantation Patients with other comorbidities that lead to an estimated life expectancy under 1 year. Patients with respiratory insufficiency which requires mechanical ventila-tion Patients with circulatory failure which requires administration of other vas-opressors (catecholamines) Patients receiving renal replacement therapy The subject is currently enrolled in another investigational device or drug trial. Patients with pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Ripoll, Prof. Dr.
Phone
+4936419
Ext
32 44 01
Email
cristina.ripoll@med.uni-jena.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Zipprich, Prof. Dr.
Phone
+4936419
Ext
32 44 01
Email
alexander.zipprich@med.uni-jena.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Ripoll, Prof. Dr.
Organizational Affiliation
Jena University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony Bruns, Prof. Dr.
Email
tbruns@ukaachen.de
Facility Name
University Hospital Dresden, Medical Clinic I, Gastroenterology
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Berning, Dr.
Phone
+49 351 458
Ext
5643
Email
Marco.Berning@uniklinikum-dresden.de
Facility Name
University Hospital Freiburg
City
Freiburg im Breisgau
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Bettinger, PD Dr.
Email
dominik.bettinger@uniklinik-freiburg.de
Facility Name
University Hospital Halle
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Greinert, Dr.
Phone
+49345557
Ext
2665
Email
robin.greinert@uk-halle.de
Facility Name
University Hospital Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Drolz, Dr.
Phone
+49 40 7410
Ext
53910
Email
a.drolz@uke.de
Facility Name
Medical University Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Maasoumy, PD Dr.
Phone
+49 511532
Ext
6814
Email
Maasoumy.Benjamin@mh-hannover.de
Facility Name
Jena University Hospital, Clinic for Inner Medicine IV
City
Jena
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Ripoll, Prof. Dr.
Phone
+4936419
Ext
324401
Email
cristina.ripoll@med.uni-jena.de
Facility Name
University Hospital Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Berg, Prof. Dr.
Phone
+49 0341 97
Ext
24831
Email
studien-hepatologie@medizin.uni-leipzig.de
Facility Name
RKH Clinic Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karel Caca, Prof. Dr.
Phone
+49 7141 99
Ext
67201
Email
karel.caca@rkh-kliniken.de
Facility Name
Ludwig-Maximilians-University, Klinikum Großhadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Lange, Prof. Dr.
Email
Christian.Lange@med.uni-muenchen.de
Facility Name
University Hospital Münster, Medical Clinic B
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonel Trebicka, Prof. Dr.
Phone
+49 251 83
Ext
57562
Email
jonel.trebicka@ukmuenster.de

12. IPD Sharing Statement

Plan to Share IPD
No

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HRS-AKI Treatment With TIPS in Patients With Cirrhosis

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