title: Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure.
abstract: OBJECTIVE
  The HepatAssist liver support system is an extracorporeal porcine hepatocyte-based bioartificial liver (BAL). The safety and efficacy of the BAL were evaluated in a prospective, randomized, controlled, multicenter trial in patients with severe acute liver failure.
  
  
  BACKGROUND
  In experimental animals with acute liver failure, we demonstrated beneficial effects of the BAL. Similarly, Phase I trials of the BAL in acute liver failure patients yielded promising results.
  
  
  METHODS
  A total of 171 patients (86 control and 85 BAL) were enrolled. Patients with fulminant/subfulminant hepatic failure and primary nonfunction following liver transplantation were included. Data were analyzed with and without accounting for the following confounding factors: liver transplantation, time to transplant, disease etiology, disease severity, and treatment site.
  
  
  RESULTS
  For the entire patient population, survival at 30 days was 71% for BAL versus 62% for control (P = 0.26). After exclusion of primary nonfunction patients, survival was 73% for BAL versus 59% for control (n = 147; P = 0.12). When survival was analyzed accounting for confounding factors, in the entire patient population, there was no difference between the 2 groups (risk ratio = 0.67; P = 0.13). However, survival in fulminant/subfulminant hepatic failure patients was significantly higher in the BAL compared with the control group (risk ratio = 0.56; P = 0.048).
  
  
  CONCLUSIONS
  This is the first prospective, randomized, controlled trial of an extracorporeal liver support system, demonstrating safety and improved survival in patients with fulminant/subfulminant hepatic failure.
authors.affiliation: Liver Support Unit, Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Suite 8215, North Tower, Los Angeles, CA 90048, USA. demetriou@csmc.edu
authors.forename: Achilles A
authors.initials: AA
authors.lastname: Demetriou
authors.forename: Robert S
authors.initials: RS
authors.lastname: Brown
authors.forename: Ronald W
authors.initials: RW
authors.lastname: Busuttil
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Fair
authors.forename: Brendan M
authors.initials: BM
authors.lastname: McGuire
authors.forename: Philip
authors.initials: P
authors.lastname: Rosenthal
authors.forename: Jan Schulte
authors.initials: JS
authors.lastname: Am Esch
authors.forename: Jan
authors.initials: J
authors.lastname: Lerut
authors.forename: Scott L
authors.initials: SL
authors.lastname: Nyberg
authors.forename: Mauro
authors.initials: M
authors.lastname: Salizzoni
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Fagan
authors.forename: Bernard
authors.initials: B
authors.lastname: de Hemptinne
authors.forename: Christoph E
authors.initials: CE
authors.lastname: Broelsch
authors.forename: Maurizio
authors.initials: M
authors.lastname: Muraca
authors.forename: Joan Manuel
authors.initials: JM
authors.lastname: Salmeron
authors.forename: John M
authors.initials: JM
authors.lastname: Rabkin
authors.forename: Herold J
authors.initials: HJ
authors.lastname: Metselaar
authors.forename: Daniel
authors.initials: D
authors.lastname: Pratt
authors.forename: Manuel
authors.initials: M
authors.lastname: De La Mata
authors.forename: Lawrence P
authors.initials: LP
authors.lastname: McChesney
authors.forename: Gregory T
authors.initials: GT
authors.lastname: Everson
authors.forename: Philip T
authors.initials: PT
authors.lastname: Lavin
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Stevens
authors.forename: Zorina
authors.initials: Z
authors.lastname: Pitkin
authors.forename: Barry A
authors.initials: BA
authors.lastname: Solomon
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001663:Bilirubin / Q000097:blood; D004867:Equipment Design; D005260:Female; D006801:Humans; D017114:Liver Failure, Acute / Q000401:mortality* / Q000628:therapy*; D019164:Liver, Artificial; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D016019:Survival Analysis
chemical_list: D001663:Bilirubin