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Baxter Healthcare Corp. said Tuesday it has stopped a U.S. test for HemAssist, a blood alternative, as the treatment group was found to have a higher incidence of death than those patients in the control group.
Baxter's Phase III U.S. surgery trial is investigating the use of its oxygen-carrying solution HemAssist as an alternative to blood in patients undergoing elective surgery, such as hip and knee replacements, aortic repair and abdominal pelvic procedures.
Baxter said that while it halted its U.S. Phase III trauma trial investigating the efficacy of HemAssist for the treatment of severe traumatic hemorraghic shock, its U.S. Phase III surgery trial has continued on track.
Baxter said it decided to stop the U.S. trauma trial, which had enrolled about 100 of its expected 850 participants, following an interim data review by the trial's independent data monitoring committee.
The committee found that patients in the treatment group had an increased mortality compared to those in the control group, the company said in a news release.
Baxter and its clinical investigators are studying the data of the trauma trial to better understand why there was a difference in mortality between the patient groups.
The patients enrolled in the U.S. trauma trial were gravely ill--victims of severe trauma, such as motor vehicle accidents, knife and gun shot wounds--and had a high expected mortality, Baxter said.
Meanwhile, Baxter said its European trauma trial, where physicians are administering HemAssist at the trauma site, is continuing on track.
Baxter said it continues to expect to bring HemAssist to market in late 1999 or early 2000.
The ongoing European trauma trial is investigating the product's efficacy in the pre-hospital setting, where doctors administer the product as a first-line therapy at the trauma site.
In contrast, U.S. doctors infused HemAssist in the hospital after patients had been in shock for much longer periods of time. The company noted that in light of the U.S. trauma results the European trauma study has been evaluated by its independent data monitoring committee and that committee has determined that the trial will continue on course.
Baxter Healthcare is the principal U.S. operating subsidiary of Baxter International Inc.
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