PILOT-CONTROLLED TRIAL OF THE EXTRACORPOREAL LIVER ASSIST DEVICE IN ACUTE LIVER-FAILURE

The objective of this pilot controlled study was to evaluate the extra corporeal liver assist device (ELAD) in patients with acute liver fail ure who were judged to still have a significant chance of survival (si milar to 50%) and in those who had already fulfilled criteria for tran splantation. Twenty-four patients were divided into two groups, 17 wit h a potentially recoverable lesion (group I) and 7 listed for transpla ntation (group II), and then randomly allocated to ELAD haemoperfusion or control. The median period of ELAD haemoperfusion was 72 hours (ra nge 3-168 h). Biocompatibility of the device was good, with no acceler ation in platelet consumption, and haemodynamic stability was maintain ed. Two patients were withdrawn from the study because of worsening of preexisting disseminated intravascular coagulation in one case and a hypersensitivity reaction in the other. Deterioration with respect to encephalopathy grade was more frequent in the control patients, 7 of 1 2 (58%), than in the ELAD-treated patients, 3 of 12 (25%). In group I where survival for the ELAD cases was 7 of 9 (78%), there was a higher than expected survival in the controls, 6 of 8 (75%). For group II ca ses, survival was 1 of 3 (33%) for the ELAD-treated patients, and 1 of 4 (25%) for the controls. Both of the survivors underwent transplanta tion. Assessment of additive function for the device revealed an impro vement in galactose elimination capacity after 6 hours of haemoperfusi on. Based on the results of this pilot-controlled trial, better indice s of prognosis will be required, in addition to those used to select f or transplantation, if patients at an earlier stage of clinical deteri oration are to be included in future studies.