Grifols APACHE Study
Research type
Research Study
Full title
Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with “Acute-On-Chronic Liver Failure” (ACLF) at High Risk of Hospital Mortality.
IRAS ID
252651
Contact name
Mireia Torres
Contact email
Sponsor organisation
Instituto Grifols S.A.
Eudract number
2016-001787-10
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
People with cirrhosis of the liver may become critically ill with acute on chronic liver failure (ACLF), where liver failure progresses and multiple other organ systems also fail. ACLF has a very high mortality and there are very few treatments that are known to be effective. The purpose of this study is to determine if Blood Plasma exchange (PE) with Albumin 5% (A) is both safe and has a beneficial effect on the progression of ACLF. PE-A is already used in other medical conditions and enables potentially toxic substances to be eliminated from the blood, whilst the plasma removed is replaced with a solution containing albumin in order to maintain cardiovascular and biochemical stability. Albumin is produced in the liver and is the most abundant protein in human plasma with an important role in maintaining blood pressure and as a transport protein for many natural substances and a variety of drugs. It is used routinely as an effective replacement fluid in many clinical conditions where blood volume must be supported, including in patients with cirrhosis. Its use in PE-A treatment may have further benefits by removing harmful albumin-bound substances and by it replacement by infusing new normal albumin. PE-A has been tested in subjects with acute liver failure, a condition that reproduces many features of ACLF, including liver failure, inflammation of body systems, multi-organ involvement and a high short-term mortality. In this condition PE-A was both safe and its use was associated with improved survival. A recent study in subjects with ACLF has also reported clinical benefits of PE with albumin. However, more data about how effective PE with albumin is in ACLF is still needed and this study aims to investigate this though its testing in a randomised clinical trial.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
18/NE/0311
Date of REC Opinion
10 Dec 2018
REC opinion
Further Information Favourable Opinion