SBIR Phase II: Development of a rapid assay for the personalized assessment of clot dysfunction due to trauma

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be to create a medical device capable of rapidly guiding treatment to stop bleeding in trauma patients. Trauma can affect the body's ability to form clots to stop bleeding. Of the more than 2 million severe cases of trauma in the U.S., approximately one third will develop a condition: trauma-induced coagulopathy (TIC), which increases mortality 4-fold. TIC can be corrected; however, current tests to identify TIC take too long to effectively guide treatment. This leads to sub-optimal care and increased mortality and morbidity. The current standard-of-care to correct TIC is the transfusion of blood products. A patient should only be transfused if necessary because unnecessary transfusions can lead to complications resulting in longer hospital stays and even death. A rapid assay that can evaluate a trauma patient's coagulation status can help guide treatment of their injuries, resulting in improved standard-of-care that can both save lives and healthcare dollars. Yearly trauma rates unfortunately remain stable, and with an addressable market of more than $400M per year in the U.S., the commercial impact for such an assay is significant. The proposed project is to develop a rapid assay that provides an individualized assessment of a trauma patient's coagulation status. A significant subset of trauma patients develop impairment to the normal coagulation process as a result of their injuries. Current assays to identify this impairment take too long to effectively guide treatment. Therefore, successful completion of this project will yield a disposable microfluidic card (microcard) that has multiple advantages over current assays, which are slow and non-specific. The microcard will measure clot characteristics currently used by emergency room physicians to guide treatment, but will do so in less than five minutes. This is a critical feature as it quickly guides treatment, meaning that there is time for re-evaluation to determine if treatment is effective. The microcard will also include on-board positive and negative controls that indicate a patient?s individual coagulation profile. This will result in personalized and more accurate treatments that can reduce complications and mortality. The rapid and specific microcard assay will significantly improve care of injured patients while conserving resources and time, ultimately saving money for the U.S. healthcare system.