The HepatAssist liver support system is an extracorporeal porcine hepatocyte-based bioartificial liver (BAL).
In this study, researchers from Europe and the United States evaluated the safety and efficacy of the BAL in patients with severe acute liver failure.
The team enrolled a total of 171 patients (86 control and 85 BAL) in the study.
They included patients with fulminant/subfulminant hepatic failure and primary nonfunction following liver transplantation.
The team identified liver transplantation, time to transplant, disease etiology, disease severity, and treatment site as possible confounding factors.
The researchers found that 30-day survival was 71% for BAL compared with 62% for the controls.
When the team excluded primary nonfunction patients, they found that survival was 73% for BAL patients and 59% for the controls. When confounding factors were considered, the team found no difference between the 2 groups.
However, survival in fulminant/subfulminant hepatic failure patients was significantly higher in the BAL patients, compared with the control group (risk ratio = 0.56).
Dr Achilles Demetriou and colleagues concluded, "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".