ALB-TRIAL
Research type
Research Study
Full title
ALB-TRIAL: Personalised long-term human albumin treatment in patients with decompensated cirrhosis and ascites.
IRAS ID
1007686
Contact name
Debbie Shawcross
Contact email
Sponsor organisation
Odense University Hospital
Eudract number
2022-501006-34
Research summary
There is an increasing burden of liver disease worldwide accounting for 2 million deaths per year, 3.5% of global mortality. Advanced liver cirrhosis brings with it a plethora of complications including bleeding, fluid accumulation in the abdomen known as ascites and a propensity to develop infections, which can lead to multiorgan failure and death. Albumin is produced in the liver and plays an important role in maintaining blood pressure and transporting proteins around the body. It is considered best practice for patients with cirrhosis to be treated with human albumin infusions if they develop ascites which needs draining. In this trial, we will investigate whether an individualised treatment with human albumin solution infused every 10 days over a period of six months can prevent new complications of cirrhosis and improve survival. At the same time, we will use a biological marker from the blood to investigate how much effect we expect to have from the treatment. We expect that the biological marker will enable future treatment with human albumin to be adapted to the individual. All participants in the trial will be first assessed by their response to an infusion of human albumin solution. This is called an albumin challenge. After one to three days, the participant will be asked to attend for a blood test which will be analysed for a biological marker. Using the biological marker from the blood, we will investigate the extent to which the participant might be expected to have a treatment effect of human albumin. Participants will be randomly allocated in a 1:1 ratio to human albumin or placebo infusions (sterile saline which will have the same salt content as the albumin) and will not contain any albumin. Both the patient and assessor will be blinded to the treatment but not the research team. 240 patients will be enrolled across Europe and the UK. The primary end-point of the trial is the cumulative number of liver-related clinical outcomes.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
23/YH/0230
Date of REC Opinion
4 Dec 2023
REC opinion
Further Information Favourable Opinion