HEAL STUDY (Hepatic Encephalopathy and Albumin Study)

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 20, 2018

Primary Completion Date

February 20, 2022

Study Completion Date

March 30, 2022

Conditions
CirrhosisHepatic EncephalopathyMinimal Hepatic EncephalopathyCovert Hepatic Encephalopathy
Interventions
BIOLOGICAL

25% IV albumin

"Intravenous 25% albumin infusion 1.0 g/kg body weight (maximum 100gm) once a week for five weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if \>4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients.~The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups."

OTHER

Placebo

"Normal saline infusion 1.0g/kg body weight once a week for five weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if \>4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients.~The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups."

Trial Locations (1)

23249

Hunter Holmes McGuire VA Medical Center, Richmond

Sponsors
All Listed Sponsors
collaborator

McGuire Research Institute

OTHER

collaborator

Instituto Grifols, S.A.

INDUSTRY

lead

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED