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Clinical Trial
. 2004 May;239(5):660-7; discussion 667-70.
doi: 10.1097/01.sla.0000124298.74199.e5.

Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure

Achilles A Demetriou  1 , Robert S Brown Jr, Ronald W Busuttil, Jeffrey Fair, Brendan M McGuire, Philip Rosenthal, Jan Schulte Am Esch 2nd, Jan Lerut, Scott L Nyberg, Mauro Salizzoni, Elizabeth A Fagan, Bernard de Hemptinne, Christoph E Broelsch, Maurizio Muraca, Joan Manuel Salmeron, John M Rabkin, Herold J Metselaar, Daniel Pratt, Manuel De La Mata, Lawrence P McChesney, Gregory T Everson, Philip T Lavin, Anthony C Stevens, Zorina Pitkin, Barry A Solomon
Affiliations
Clinical Trial

Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure

Achilles A Demetriou et al. Ann Surg. 2004 May.

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.

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Figures

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FIGURE 1. Schematic outline of the BAL and the bioreactor cartridge loaded with microcarrier-attached porcine hepatocytes.
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FIGURE 2.A: Time to death in FHF/SHF patients (n = 147; P = 0.10). B: Time to death in patients with FHF/SHF of known etiology (n = 83; P = 0.009).
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FIGURE 3. Total serum bilirubin levels (mean ± SD).
See this image and copyright information in PMC

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