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Prospective, Randomized, Multicenter, Controlled Trial of a Bioartificial Liver in Treating Acute Liver Failure

Open access
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.·2004·Annals of Surgery

Abstract

In Brief 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. A prospective randomized trial of the HepatAssist bioartificial liver support system was carried out in patients with fulminant/subfulminant hepatic failure and primary nonfunction following liver transplantation. Treated fulminant/subfulminant hepatic failure patients had improved survival compared with controls when the effect of confounding factors was accounted for in the data analysis.

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Metadata

Authors
Demetriou, A. A., Brown, R. S., Busuttil, R. W., Fair, J., McGuire, B. M., Rosenthal, P., Am Esch, J. S., Lerut, J., Nyberg, S. L., Salizzoni, M., Fagan, E. A., de Hemptinne, B., Broelsch, C. E., Muraca, M., Salmeron, J. M., Rabkin, J. M., Metselaar, H. J., Pratt, D., De La Mata, M., McChesney, L. P., Everson, G. T., Lavin, P. T., Stevens, A. C., Pitkin, Z., & Solomon, B. A.
Venue
Annals of Surgery
Published
2004-05
Volume
239
Issue
5
Pages
660-670
ISSN
0003-4932 (ISSN-L)
OpenAlex
W1971200468
Cited by
677
References
13
FWCI
31.31
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Prospective, Randomized, Multicenter, Controlled Trial of a Bioartificial Liver in Treating Acute Liver Failure. https://app.cochat.ai/papers/10.1097/01.sla.0000124298.74199.e5
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Demetriou, A. A., Brown, R. S., Busuttil, R. W., Fair, J., McGuire, B. M., Rosenthal, P., Am Esch, J. S., Lerut, J., Nyberg, S. L., Salizzoni, M., Fagan, E. A., de Hemptinne, B., Broelsch, C. E., Muraca, M., Salmeron, J. M., Rabkin, J. M., Metselaar, H. J., Pratt, D., De La Mata, M., . . . Solomon, B. A. (2004). Prospective, Randomized, Multicenter, Controlled Trial of a Bioartificial Liver in Treating Acute Liver Failure. Annals of Surgery. https://doi.org/10.1097/01.sla.0000124298.74199.e5

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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