Steven Martin 0

Hemopure Trial: A Life saving petition

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************************************************************************************************** An internal U.S. Navy report condemns the Food and Drug Administration for half a decade of stone walling clinical trials of a potentially life saving drug. Why should you care Many trauma victims die from blood loss on the way to the hospital, and Hemopure can deliver oxygen in blood when red cell transfusions are not an option. The FDA cites concerns that the product may not be as safe as blood. But the Navy hopes to save wounded battlefield victims bleeding to death when blood is not available! Who wouldn't take a small risk for the chance to live Joseph Acker, executive director of Birmingham Regional Emergency Medical Services System has gone on record saying; "If we can get a blood substitute, it would make all the difference in the world. It would probably save more lives than anything we could do in EMS."( Ref: A Press Release in the Boston Globe on April 4, 2009 relating to an internal Navy Report) ************************************************************************************************** Hemopure is a hemoglobin based oxygen therapeutic that is intravenously administered to maintain the circulatory system and deliver oxygen to the body. It is ideally suited for use outside the hospital. * Does not need cross matching. It is universally accepted * Can be stored at room temperature for up to 36 months * Is not subject to blood born diseases (AIDs, HEP C, Chagas, etc) *Far smaller than a red blood cell-allows perfusion through restricted vessels * May provide a suitable alternative to those who refuse blood transfusions Hemopure has been used to support a compassionate use case for 18 days when the patient had a red blood cell hematocrit of less than five (normal is 33). It is ironic that the FDA continues to approve use of the product in individual compassionate use cases but despite the Navy providing answers to all questions asked, a trial to study this benefit for the rest of us is still being denied. ************************************************************************************************** The Navy currently has proposed and submitted a new IND protocol that will test the product with full informed consent of patients, and has made many changes to previous protocols in an effort to satisfy the FDA Blood Products Advisory Committee, yet all of these efforts have been overruled. The proposed study named OpRESUS is designed to measure safety of the product and to improve survival of gravely traumatized victims. This trial must be approved by FDA to determine the products effectiveness, and potential for further uses, as all of the trauma evidence to date warrants further examination of this product. (See Pubmed for specific articles on Hemopure or HBOC-201) This petition is a request that the Navy trial be approved and begins immediately. Troop and civilian lives are in the balance!


This petition is sponsored by concerned citizens for change relating to FDA evaluation of Hemoglobin Based Oxygen Carriers (HBOC). These fluids, if used properly, can have a marked impact on survival of those suffering from traumatic injury, both military and civilian.
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