Hemopure clinical trial
U.S. Naval Medical Research Center (NMRC) has submitted to the FDA a revised investigational new drug application to begin a clinical trial of Hemopure® [hemoglobin glutamer - 250 (bovine)], a stabilized hemoglobin, for pre-hospital battlefield treatment of trauma patients. The study is entitled “Operation Restore Effective Survival in Shock” (Op RESUS).
The drug, a product of Biopure Corp, a Cambridge, Mass company, has been under development for many years now. At present, Hemopure® has been approved for marketing in South Africa, where it is “indicated for the treatment of adult surgical patients who are acutely anaemic. Hemopure is indicated for the purpose of eliminating, delaying, or reducing the need for allogenic red blood cells.” The company says Hemopure provides “an oxygen treatment bridge” in surgical patients by buying time for patients to build up their own reserves of red blood cells following surgery, hence eliminating the need for red blood cell transfusions in the immediate post operative period.
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