Baxter's HemAssist Enters Ph III

9 December 1996

Baxter Healthcare's hemoglobin therapeutic, HemAssist (diaspirin cross-linked hemoglobin), an oxygen-carrying intravenous solution, has been cleared by the US Food and Drug Administration to enter Phase III clinical trials in patients with blood loss and shock caused by severe trauma. According to the company, this is the first "blood substitute" of its kind to reach advanced-stage surgery and trauma research.

Its multicenter, randomized, double-blinded trial investigating the effects of HemAssist in surgery is expected to last approximately 18 months. Patients are continuing to be enrolled in this trial, whereas the trauma trial, which will determine the use of HemAssist on the survival rates in patients who suffer severe trauma, will begin enrolling patients in the USA, in early 1997.

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