APTITUDE MEDICAL SYSTEMS INC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT ABSTRACT Trauma is the leading cause of death and disability worldwidekilling more people under the age ofthan all other causes combinedCoagulopathy in trauma patients can result from multiple factorstrauma induced coagulopathyTICan endogenous state of impaired coagulation that happens before treatmentis consistently identified in a quarter of trauma patientssuboptimal care of patientssuch as hypothermia or hemodilutioncan also cause or further compound coagulopathyGiven thatof deaths caused by trauma coagulopathy occur within the first hourrapid detection and aggressive correction of the condition can dramatically improve patient outcomes and save livesFibrinogen plays a crucial role in the pathogenesis and management of trauma coagulopathyFibrinogen is the most vulnerable coagulation factor during hemorrhagereaching critically low levels earlier than any other factorPrompt measurement and data driven replacement of fibrinogen is now part of current European guidelines for management of hemorrhage and coagulopathy and is increasingly advocated for in the USEarly measurement of fibrinogen is actionableit can not only guide decisions on fibrinogen replacementbut also facilitate other clinical decisions for managing coagulopathysuch as initiation of massive transfusionWe propose to create a rapid POC test for fibrinogenwith a simple and robust design to enable use in prehospital and Emergency DepartmentEDsettingsWe will use our device to measure whole blodd and plasma samples frompatients in phaseand compare with the commonly used Clauss assayIf successfulthis work has the potential to yield the first point of care fibrinogen test to provide life saving information at the time of need NARRATIVE Trauma is the leading cause of death and disability worldwidekilling more people under the age ofthan all other causes combinedTrauma coagulopathy is highly correlated with patient mortality and morbidityrapid detection and aggressive correction of the condition can dramatically improve patient outcomes and save livesWe propose to develop a simplerapid diagnostic for Fibrinogenwhich is an early marker for fibrinogen deficit and trauma coagulopathyand have clear clinical implicationIf successfulthis project has the potential to effectively manage trauma coagulopathyimprove patient outcomeand save lives!