Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure. Academic Article uri icon

Overview

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. SUMMARY BACKGROUND DATA: 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

  • Demetriou, Achilles A
  • Brown, Robert S.
  • Busuttil, Ronald W
  • Fair, Jeffrey
  • McGuire, Brendan M
  • Rosenthal, Philip
  • Am Esch, Jan Schulte
  • Lerut, Jan
  • Nyberg, Scott L
  • Salizzoni, Mauro
  • Fagan, Elizabeth A
  • de Hemptinne, Bernard
  • Broelsch, Christoph E
  • Muraca, Maurizio
  • Salmeron, Joan Manuel
  • Rabkin, John M
  • Metselaar, Herold J
  • Pratt, Daniel
  • De La Mata, Manuel
  • McChesney, Lawrence P
  • Everson, Gregory T
  • Lavin, Philip T
  • Stevens, Anthony C
  • Pitkin, Zorina
  • Solomon, Barry A

publication date

  • May 1, 2004

Research

keywords

  • Liver Failure, Acute
  • Liver, Artificial

Identity

PubMed Central ID

  • PMC1356274

Scopus Document Identifier

  • 11144356892

PubMed ID

  • 15082970

Additional Document Info

volume

  • 239

issue

  • 5