title: ATTIRE: Albumin To prevenT Infection in chronic liveR failurE: study protocol for a single-arm feasibility trial.
abstract: BACKGROUND
  Circulating prostaglandin E2 levels are elevated in acutely decompensated cirrhosis and have been shown to contribute to immune suppression. Albumin binds and inactivates this hormone. Human albumin solution could thus be repurposed as an immune restorative drug in these patients.This feasibility study aims to determine whether it is possible and safe to restore serum albumin to >30 g/L and maintain it at this level in patients admitted with acute decompensated cirrhosis using repeated 20% human albumin infusions according to daily serum albumin levels.
  
  
  METHODS
  Albumin To prevenT Infection in chronic liveR failurE (ATTIRE) stage 1 is a multicentre, open label dose feasibility trial. Patients with acutely decompensated cirrhosis admitted to hospital with a serum albumin of <30 g/L are eligible, subject to exclusion criteria. Daily intravenous human albumin solution will be infused, according to serum albumin levels, for up to 14 days or discharge in all patients. The primary end point is daily serum albumin levels for the duration of the treatment period and the secondary end point is plasma-induced macrophage dysfunction. The trial will recruit 80 patients. Outcomes will be used to assist with study design for an 866 patient randomised controlled trial at more than 30 sites across the UK.
  
  
  BACKGROUND
  Research ethics approval was given by the London-Brent research ethics committee (ref: 15/LO/0104). The clinical trials authorisation was issued by the medicines and healthcare products regulatory agency (ref: 20363/0350/001-0001).
  
  
  RESULTS
  Will be disseminated through peer reviewed journals and international conferences. Recruitment of the first participant occurred on 26/05/2015.
  
  
  BACKGROUND
  The trial is registered with the European Medicines Agency (EudraCT 2014-002300-24) and has been adopted by the NIHR (ISRCTN 14174793). This manuscript refers to V.4.0 of the protocol; Pre-results.
authors.affiliation: Division of Medicine, University College London (UCL), London, UK.
authors.forename: Louise
authors.identifier: http://orcid.org/0000-0001-5870-2310
authors.initials: L
authors.lastname: China
authors.affiliation: Comprehensive Clinical Trials Unit, University College London (UCL), London, UK.
authors.forename: Nicola
authors.initials: N
authors.lastname: Muirhead
authors.affiliation: Comprehensive Clinical Trials Unit, University College London (UCL), London, UK.
authors.forename: Simon S
authors.identifier: http://orcid.org/0000-0002-7828-3122
authors.initials: SS
authors.lastname: Skene
authors.affiliation: Comprehensive Clinical Trials Unit, University College London (UCL), London, UK.
authors.forename: Zainib
authors.initials: Z
authors.lastname: Shabir
authors.affiliation: Division of Medicine, University College London (UCL), London, UK.
authors.forename: Roel P H
authors.initials: RP
authors.lastname: De Maeyer
authors.affiliation: Division of Medicine, University College London (UCL), London, UK.
authors.forename: Alexander  A N
authors.initials: A
authors.lastname: Maini
authors.affiliation: Division of Medicine, University College London (UCL), London, UK.
authors.forename: Derek W
authors.initials: DW
authors.lastname: Gilroy
authors.affiliation: Division of Medicine, University College London (UCL), London, UK.
authors.forename: Alastair J
authors.initials: AJ
authors.lastname: O'Brien
mesh_terms: D000328:Adult; D000368:Aged; D000418:Albumins / Q000008:administration & dosage*; D002985:Clinical Protocols; D003428:Cross Infection / Q000517:prevention & control*; D016207:Cytokines / Q000378:metabolism; D058625:End Stage Liver Disease / Q000150:complications*; D005240:Feasibility Studies; D006801:Humans; D007262:Infusions, Intravenous; D008103:Liver Cirrhosis / Q000150:complications*; D008264:Macrophages / Q000276:immunology; D008875:Middle Aged; D012709:Serum Albumin / Q000378:metabolism; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000418:Albumins; D016207:Cytokines; D012709:Serum Albumin
keywords: Albumin; Liver Cirrhosis; Prostaglandin E2
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