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


BACKGROUND
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.
Demetriou
Achilles A
AA
Liver Support Unit, Department of Surgery, Cedars-Sinai Medical Center, 8700 Beverly Boulevard, Suite 8215, North Tower, Los Angeles, CA 90048, USA. demetriou@csmc.edu
Brown
Robert S
RS
Busuttil
Ronald W
RW
Fair
Jeffrey
J
McGuire
Brendan M
BM
Rosenthal
Philip
P
Am Esch
Jan Schulte
JS
Lerut
Jan
J
Nyberg
Scott L
SL
Salizzoni
Mauro
M
Fagan
Elizabeth A
EA
de Hemptinne
Bernard
B
Broelsch
Christoph E
CE
Muraca
Maurizio
M
Salmeron
Joan Manuel
JM
Rabkin
John M
JM
Metselaar
Herold J
HJ
Pratt
Daniel
D
De La Mata
Manuel
M
McChesney
Lawrence P
LP
Everson
Gregory T
GT
Lavin
Philip T
PT
Stevens
Anthony C
AC
Pitkin
Zorina
Z
Solomon
Barry A
BA
D000293:Adolescent; D000328:Adult; D000368:Aged; D001663:Bilirubin / Q000097:blood; D004867:Equipment Design; D005260:Female; D006801:Humans; D017114:Liver Failure, Acute / Q000401:mortality* / Q000628:therapy*; D019164:Liver, Artificial; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D016019:Survival Analysis
D001663:Bilirubin