TY - JOUR
T1 - Prospective, Randomized, Multicenter, Controlled Trial of a Bioartificial Liver in Treating Acute Liver Failure
AU - Demetriou, Achilles A.
AU - Brown, Robert S.
AU - Busuttil, Ronald W.
AU - Fair, Jeffrey
AU - McGuire, Brendan M.
AU - Rosenthal, Philip
AU - Am Esch, Jan Schulte
AU - Lerut, Jan
AU - Nyberg, Scott L.
AU - Salizzoni, Mauro
AU - Fagan, Elizabeth A.
AU - De Hemptinne, Bernard
AU - Broelsch, Christoph E.
AU - Muraca, Maurizio
AU - Salmron, Joan Manuel
AU - Rabkin, John M.
AU - Metselaar, Herold J.
AU - Pratt, Daniel
AU - De La Mata, Manuel
AU - McChesney, Lawrence P.
AU - Everson, Gregory T.
AU - Lavin, Philip T.
AU - Stevens, Anthony C.
AU - Pitkin, Zorina
AU - Solomon, Barry A.
AU - Henderson, J. Michael
AU - Chari, Ravi S.
AU - Meyers, William C.
AU - Wood, William C.
PY - 2004/5
Y1 - 2004/5
N2 - 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.
AB - 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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U2 - 10.1097/01.sla.0000124298.74199.e5
DO - 10.1097/01.sla.0000124298.74199.e5
M3 - Article
C2 - 15082970
AN - SCOPUS:11144356892
VL - 239
SP - 660
EP - 670
JO - Annals of surgery
JF - Annals of surgery
SN - 0003-4932
IS - 5
ER -