Baxter's HemAssist Fails In Phase III Trauma Study

Baxter International has terminated a Phase III trial of its bloodsubstitute HemAssist (diaspirin cross-linked hemoglobin) in the treatment of severe hemorrhagic shock following interim data analysis which demonstrated increased mortality in the treatment group compared to the control group. The company had only enrolled 100 of the planned 850 participants.

However, a US Phase III trial of HemAssist in patients undergoing elective surgery is ongoing, as is a European trauma study, in which the product is administered at the trauma site.

Baxter says that the US trauma trial differed from the European one in that HemAssist was administered to patients in the hospital setting after they had been in trauma for a much longer period of time. It added that participants involved in this trial were "among the most severely injured of all trauma victims, with only about 3%...eligible for trial inclusion." In light of the US trial results, the European study was evaluated by an independent data monitoring committee which concluded that the trial should continue.