As a practicing Anesthesiologist, providing care personally, and supervising Anesthesiology Residents and Nurse Anesthetists, I have first-hand knowledge and experience in dealing with devastating traumatic hemorrhagic shock (THMS). With poor survival due to inadequate current resuscitation fluid used in the field, a more effective solution is required for improving outcome. As Interim Chair of Anesthesiology for the past 23 years and Trauma Clinical Trials Research Director at a traditionally underserved minority institution for two years, I witnessed how disparities in healthcare lead to worse outcomes in trauma. For the past 23 years, in basic science, translational and clinical models/trials, I have devoted my energy to understanding the pathophysiology, pharmacology and management of THS with over 100 peer reviewed publications, especially with regard attention to oxygen carriers, and specifically to the coagulopathic effects of these products. Notably, recently I led a Phase III clinical trial of a leading HBOC product which resulted in a publication, which is considered as one of the key publications in the field (Jahr et al., 2008). This work while presenting an Invited Plenary Lecture at the XII International Symposium on Blood Substitutes, Parma, Italy, entitled: Clinical and Translational Advances in Blood Substitutes--One Investigators Perspective, I proposed a Consortium approach for new development of blood substitute science. My expertise, extensive experience, and leadership roles in the resuscitation fluid research has enabled me to guide this form a Consortium of world class thought leaders and researchers in this area, and based on the goals of the consortium, to transition from oxygen carriers, to study the therapeutic potential provide outstanding science in a transformational area of multifunctional resuscitation fluids, (specifically a Small volume Multifunctional Emergency Resuscitation Fluid (: SMERF) consisting of a plasma expander, an oxygen carrier, coagulation factors and other beneficial mediators as a potential universal resuscitation fluid for field treatment of THS. Potential bias due to conflict-of-interest issues for industry sponsored investigators has been well recognized. Therefore, to conduct objective evaluations, SMERF must be studied without the influence of component manufacturers of the components (oxygen carrier, coagulation factors, fluids, other beneficial mediators) and be able to be reported in an unbiased way; the independence of consortium investigators will allow objective assessment of candidate SMERFs. Further, the safety and efficacy of candidate SMERFs will be evaluated by blinding of test materials and adoption of randomized study designs, similar to clinical trials (but uncommon in basic/translational research) The development of a model that includes blinded testing of the candidate SMERF products, amongst the 4 sites with well-established stellar scientific models and publications in this exact area, to vet these products and evaluate safety and efficacy in translational models is unparalleled. This project and call provide an outstanding platform on which to create, develop, and study this novel SMERF, so that a final product will emerge that can be vetted and approved by the Food and Drug Administration (FDA) for an IND Investigational New Drug (IND) Application, leading into FDA sponsored guided human Phase I through III trials, and eventual approval for human use. Consultant scientists from the FDA and the UCLA Director of Clinical and Translational Science Institute (CTSI) will participate in all critical decision points during the conduct of the grant. The potential for this fluid is truly revolutionary and if successful, will transform the field of resuscitation medicinal and allow for survival of trauma victims. The potential for this fluid is truly revolutionary and if successful, will transform the field of resuscitation medicine and allow for improved survival of trauma victims. My recent training in Executive Leadership at the UCLA Anderson School of Management will enable me to leverage the knowledge and abilities gained, to conduct the science and administration of this transformational grant in an exemplary manner. In summary, I have the expertise, experience and leadership to lead and manage the proposed research project to a successful solution.
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