Status:
UNKNOWN
Body Composition Changes After TIPS and Associated Clinical Outcomes
Lead Sponsor:
Oregon Health and Science University
Conditions:
Cirrhosis, Liver
Sarcopenia
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to prospectively assess the impact of TIPS creation on muscle mass and physical function in patients with cirrhosis, and to determine whether these changes correlate with ...
Detailed Description
Sarcopenia (loss of muscle mass) and frailty (loss of muscle function) have increasingly become recognized as major prognostic factors in predicting morbidity and mortality with several disease states...
Eligibility Criteria
Inclusion
- Patients \>18 \<99 with cirrhosis wait listed for liver transplantation
- Evidence of complications of portal hypertension:
- Ascites or hydrothorax requiring escalation of diuretic medication
- Persistent ascites or hydrothorax despite diuretic use, or intolerance of diuretic use
- Gastrointestinal varices and blood loss anemia or history of variceal hemorrhage
- Portal hypertensive gastropathy and blood loss anemia
- Chronic portal vein thrombosis requiring recanalization and TIPS for transplant
Exclusion
- Hepatocellular carcinoma or other active malignancy
- Recurrent overt hepatic encephalopathy
- Uncontrolled coagulopathy with maximum amplitude (MA) \<30 on thromboelastography
- Bacteremia or sepsis
- MELD \> 25
- Pregnant
- Decisionally impaired individuals
- Need for emergency TIPS creation
- Patients who do not have acceptable alternatives to TIPS creation to manage their disease
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05420753
Start Date
May 1 2022
End Date
December 31 2025
Last Update
November 7 2023
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239