Prospective, randomized, multicenter, controlled trial of a bioartificial liver in treating acute liver failure
| Autor: | John M. Rabkin, Jan Lerut, Maurizio Muraca, Daniel S. Pratt, Christoph E. Broelsch, Lawrence P. McChesney, Ronald W. Busuttil, Philip J. Rosenthal, Brendan M. McGuire, Philip T. Lavin, Bernard de Hemptinne, Joan Manuel Salmerón, Barry A. Solomon, Jeffrey H. Fair, Elizabeth A. Fagan, Jan Schulte am Esch, Manuel de la Mata, Zorina Pitkin, Mauro Salizzoni, Scott L. Nyberg, Herold J. Metselaar, Achilles A. Demetriou, Gregory T. Everson, Anthony C. Stevens, Robert S. Brown |
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| Přispěvatelé: | Gastroenterology & Hepatology |
| Rok vydání: | 2004 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent medicine.medical_treatment Fulminant Liver transplantation Gastroenterology law.invention Original Articles and Discussions Randomized controlled trial law Multicenter trial Internal medicine Humans Medicine Prospective Studies Aged Proportional Hazards Models Liver support systems business.industry Bioartificial liver device Bilirubin Equipment Design Liver Failure Acute Middle Aged Liver Artificial Survival Analysis Surgery Clinical trial Relative risk Female business |
| Zdroj: | Annals of Surgery, 239(5), 660-670. Lippincott Williams & Wilkins |
| ISSN: | 0003-4932 |
| DOI: | 10.1097/01.sla.0000124298.74199.e5 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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