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Imagine these hypothetical situations; you are injured and lying on the battlefield or are involved in a serious automobile accident and require a blood transfusion. What are the medical treatment options in these scenarios?
"In the past, the standard procedure is for trauma units to use saline solution to restore blood volume and increase the likelihood of survival after traumatic injury. If organs do not receive enough oxygen, organ damage or death usually occurs."
"In circumstances where a patient at least eighteen years old is in critical condition at the scene of the injury, random patients either received saline solution or PolyHeme for up to twelve hours as needed after transported to selected trauma centers. It was one of the few candidates to complete phase III clinical trials, but it also failed to win approval with an unfavorable risk-benefit assessment."
"In 2008, the Journal of American Medical Association released the paper, Cell-Free Hemoglobin Based Blood Substitutes and Risk of Myocardial Infarction and Death, which is a meta-analysis study of 16 clinical trials of blood substitutes, including 5 products, and 3711 patients. The paper was the bearer of bad news as it revealed patients in clinical trials had a 30 percent greater chance of death when compared to a control group."
Drawing a conclusion from a meta analysis on five different products makes no sense at all. Further, it's pretty obvious that the control group were given blood while the purpose of the blood substitutes is to provide an oxygen carrying fluid when blood is unavailable.
How could the FDA possibly come to the conclusion that they did? So if blood is unavailable and Polyheme is, the patient will probably live. With only saline available, the patient will certainly die. That's an unfavorable risk-benefit? Personally, I'd take the risk of Polyheme over the prospect of certain death or organ failure with saline.
I'd be interested in your thoughts on this. There must be more to the FDA's reasoning. What is it?
Posted by Milton Martinez on 07/03 at 09:08 AM
Hemoglobin Based Oxygen Carriers outside of red blood cells provide oxygen but also absorb Nitric Oxide which helps to keep arteries from constricting which causes heart attacks.
Realizing this danger should alter the thinking of HBOC researchers.
Perhaps a combination of saline solution and smaller amounts of HBOC's might be in order. A balance between providing oxygen and minimizing the absorption of Nitric Oxide has to be achieved if the FDA is going to approve HBOC's.
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