HEAL STUDY (Hepatic Encephalopathy and Albumin Study)
Completed · Phase 2 · Has a placebo group
Conditions studied: Cirrhosis, Hepatic Encephalopathy, Minimal Hepatic Encephalopathy, Covert Hepatic Encephalopathy
In brief
Patients with continued cognitive impairment after episodes of HE have few options beyond lactulose and rifaximin in the US. Therefore using IV albumin in a randomized, double-blind, placebo-controlled trial, which could beneficially impact inflammation, could be an additional approach to improve cognition. This 6 week trial will study changes in cognition, HRQOL and inflammation in patients with covert HE after prior overt HE using multiple IV albumin infusions vs. placebo.
Key facts
- Study ID
- NCT03585257
- Run by
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- People needed
- 48
- Starts
- 2018-06-20
- Expected to finish
- 2022-03-30
- Last updated by the study team
- 2022-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age >18 years
- Cirrhosis defined by any one of the following
- Cirrhosis on liver biopsy or transient wave elastography
- Nodular liver on imaging
- Endoscopic or radiological evidence of varices in a patient with chronic liver disease
- Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
- Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
- Prior HE controlled on standard of care therapy defined as lactulose or rifaximin for at least 2 months prior to enrollment.
- Serum albumin <4 gm/dl
- Cognitive impairment on any of the three testing strategies for HE including Psychometric hepatic encephalopathy score (PHES), Stroop test and Critical Flicker Frequency
- PHES aggregate score <-4SD based on norms published in Allampati et al located at the website www.encephalapp.com
- Stroop OffTime+OnTime values greater than norms published in Allampati et al located at the website www.encephalapp.com
- Critical Flicker Frequency value <39 Hz
You may not qualify if…
- Unclear diagnosis of cirrhosis (does not meet the criteria outlined above)
- No prior overt HE episodes
- HE uncontrolled on standard of care defined as a mini-mental status exam<25
- On regular IV albumin infusions due to scheduled paracentesis within the last 3 months
- Recent alcohol abuse (within 3 months)
- Unable to give consent
- Current or recent invasive bacterial or fungal infections (<1 month)
- Allergic reactions to IV albumin
- Current or recent congestive heart failure (Systolic ejection fraction <25%) within the last year
- Pregnancy (positive urine pregnancy test at screening)
- In the opinion of the PI, those who are unlikely to survive 6 weeks or be able to adhere to the trial activities.
Where it is running
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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