[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520100":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":27,"enrollmentInfo":78,"targetDuration":27,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":37,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Hunter Holmes Mcguire Veteran Affairs Medical Center","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Saline given at the same volume as the albumin on visits the patients are assigned to it",[13],"Drug: Albumin Infusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Albumin","ACTIVE_COMPARATOR","IV Albumin at 1.5g\u002Fkg ideal body weight",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Albumin Infusion","Intravenous human serum albumin to be given at 1.5g\u002Fkg ideal body weight",[15,9],[26],"Albutein",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Jasmohan Bajaj, MD","CONTACT","8046755802","jasmohan.bajaj@vcuhealth.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hunter Holmes McGuire VA Medical Center","RECRUITING","Richmond","Virginia","23249","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-77.46026,37.55376,{"lat":47,"lon":46},[50,55,59],{"name":51,"role":31,"phone":52,"phoneExt":53,"email":54},"Haley Obolewicz, RN","804 675 5000","6733","haley.obolewicz@va.gov",{"name":56,"role":31,"phone":57,"phoneExt":27,"email":58},"Travis Mousel, RN","804 675 5584","travis.mousel@va.gov",{"name":60,"role":61,"phone":27,"phoneExt":27,"email":27},"Jasmohan S Bajaj, MD, MSc","PRINCIPAL_INVESTIGATOR",{"type":63,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[65],{"name":66,"class":67},"Grifols Biologicals, LLC","INDUSTRY","100520100","phase-2-hepatic-encephalopathy-and-albumin-lasting-cognitive-improvement-100520100",false,"NCT06052176","Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement","Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin","HEAL-LAST","Inclusion Criteria:\n\n* Age \\>18 years\n* Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\\>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with chronic liver disease, platelet count \\\u003C150,000\u002Fmm3 and AST\u002FALT ratio \\>1.\n* Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop\n* Prior HE controlled by lactulose or rifaximin for at least one month\n* Serum albumin \\\u003C4gm\u002Fdl\n\nExclusion Criteria:\n\n* Unclear diagnosis of cirrhosis\n* No prior overt HE\n* No cognitive impairment on the tests noted\n* Requiring regular albumin infusions within 3 months or anticipated during the study visit\n* Infection within a month\n* Allergies to albumin\n* Unlikely to be adherent to the study\n* Unable or unwilling to consent\n* West Haven Criteria\\>2\n* Alcohol abuse within 1 month\n* Serum albumin \\>4gm\u002Fdl\n* Congestive heart failure","ALL","18 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes.\n\nThis will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.",[86,87],"Cirrhosis","Hepatic Encephalopathy",[89,90,91,92],"albumin","cirrhosis","inflammation","cognitive performance","2026-04-02",{"date":95,"type":96},"2026-04-08","ACTUAL",{"date":98,"type":96},"2023-11-02",{"date":100,"type":80},"2026-12-01",{"name":5,"class":6},1]