Survival rate rises with use of bioartificial liver support system. (Randomized Trial Data).

NEW YORK -- The first randomized, prospective, controlled trial of a liver-assist system for patients with fulminant hepatic failure showed a survival advantage with the system, Dr. Achilles Demetriou reported at the annual conference of the American Society for Artificial Internal Organs.

Previous clinical trials of liver-assist or -support devices and systems have not been randomized.

The 30-day survival rate for the 147 fulminant hepatic failure patients in the study was 59% for patients randomized to the regular standard of care (SOC) and 73% for patients treated with the standard of care plus the HepatAssist bioartificial liver support system. The system is an extracorporeal circuit comprised of a hollow fiber cartridge containing porcine hepatocytes, coupled with charcoal in a plasma-perfused circuit.

Serious adverse events were balanced in both treatment groups in this phase II/III clinical trial.

"The survival advantages, viewed with the safety data, support the use of the system for the treatment of fulminant hepatic failure," said Dr. Demetriou of Cedars-Sinai Medical Center, Los Angeles. "There is no current technology to replace liver function and all of its complexities. Instead, what is being sought is a device that eliminates toxins and/or regenerates liver cells and ultimately acts as a bridge to ...