This is why Northfield Labs AND the FDA agreed to the 12 hours post arrival at hospital (via Special Protocol Agreement). In my opinion.
Polyheme may actually be better than blood.
http://www.bioethics.net/journal/j_articles.php?aid=998
Critics argue that, despite acknowledged limitations of banked blood, its general acceptance in resuscitation is prima facie evidence of its “satisfactory” nature. Once blood is available, they profess, randomization should be reserved for consenting subjects.
Is the efficacy and safety of transfused blood “proven”? Despite its widespread use and acceptance, the performance of banked blood has never been subjected to the level of scrutiny imposed on investigational new drugs. Transfusions fail to improve oxygen consumption in critically ill patients (Fernades et al. 2001). Attendant risks of transfusion reaction and transmission of infection are universally recognized. Few accept transfusion absent life-threatening anemia.
Is the transfusion of banked blood “satisfactory”? Clearly, it is an effective means of immediate resuscitation in hemorrhagic shock, but at what price? Clinical trials have demonstrated that transfusion increases the incidence of multiorgan failure (MOF) and increases mortality (Kao 2000; Johnson et al. 2001). In particular, transfusion of six or more units within the first 12 hours is the primary risk factor for MOF, independent of injury severity (Moore, Moore and Sauaia 1997). MOF is the leading cause of post-injury death, conferring a mortality of 35% and prolonging ICU stays an average of one month with mechanical ventilation and dialysis. The adverse effect on outcomes is not limited to trauma victims, but is particularly pertinent to this population because of the pathophysiology of transfusion-related injury (Corwin et al. 2004; Herbert and Fergusson 2004; Napolitano 2004; Rao et al 2004). Many thoughtful clinicians feel treatment that increases mortality and organ failure is unsatisfactory.
How could blood be bad? It’s a universal natural product that serves us well. Banked blood, however, is artificially preserved and gradually degrades with its 42-day storage, releasing from red cell membranes lipid mediators and cytokines. These factors combine with traumatized tissue in a two-step priming of neutrophils and oxygen radical production, each of which is highly correlated with development of MOF (Moore, Moore and Sauaia 1997; Johnson et al. 2001). Transfused units are necessarily the oldest in the blood bank with the highest concentration of toxins. Furthermore, trauma patients requiring massive transfusions first receive unmatched blood. Type-specific blood requires up to 20 additional minutes to deliver and fully cross-matched blood can require 45 minutes. The risk of immunologic complications and medical error increases under the pressure of emergency delivery. Blood’s failure to improve oxygen consumption in critically ill patients apparently stems from changes in red cell deformability with storage. Such rheologic changes can produce red cell entrapment, microvascular obstruction and tissue ischemia (Fernandes et al. 2001; Berezina et al. 2002).
By contrast, PolyHeme® has a long shelf life and is compatible with all blood types. The risk of viral and bacterial transmission is extremely low. Extensive pre-clinical and earlier clinical studies have shown very few adverse effects. Deleterious vasoconstrictive effects that have plagued earlier blood substitutes are noticeably absent with this product
