Blaze Medical Devices — Department of Health and Human Services SBIR Phase I: NHLBI

Description

DESCRIPTION provided by applicant Blaze Medical Devices Blaze is dedicated to improving the safety and the efficacy of the nationandapos s blood supply Blaze is developing a test to quantify the prospective efficacy of each Red Blood Cell RBC unit The need for such testing is predicated upon the adverse effects and unpredictable efficacy of transfused RBC due to inter donor variability differences in manufacturing methods and prolonged RBC storage Significant data show that these differences can cause ambiguities about the quality of individual RBC units that time alone cannot adequately reflect For million units of pRBC transfused annually in the US the cost of suboptimal efficacy by itself has been estimated at about $ billion RBC mechanical fragility MF reflects an array of biochemical and biomechanical changes during storage and tracks the loss of plasticity that red blood cells need to survive in vivo and to deliver oxygen effectively MF had been proposed as an in vitro metric potentially predictive of transfusion outcomes However the clinical relevance of such a metric still remains to be demonstrated The hypothesis of the Phase I research is that RBC MF can be used as an aggregate parameter predictive of RBC survival post transfusion and that this is at least partially time independent In this project Blazeandapos s Phase I Specific Aim is to establish the reliability of RBC mechanical fragility as a metric of post transfusion performance measured through incremental patient hematocrit and total hemoglobin primary outcomes and Specific Aim is to establish the reliability of RBC mechanical fragility as a metric of post transfusion performance measured through in vivo hemolysis markers of plasma Hb bilirubin haptoglobin and LDH secondary outcomes Phase II research will further validate the RBC in vitro MF as a metric to predict transfusion outcomes and optimize the test for clinical use Blaze will provide base devices and consumables for RBC mechanical fragility testing The innovation of Blazeandapos s product can solve the longstanding problem of MF testing being difficult to standardize for wide acceptability by offering a rapid and reliable test that requires very little sample to generate data rich multi dimensional fragility profiles by utilizing its patented optical and processing techniques The long term goal of the project is to improve the efficacy and safety of blood transfusions through quantifying and potentially predicting the changes in RBC viability during storage As a first commercial application Blazeandapos test will enable more efficient management of Hospital Blood Bank inventories for example by switching from the current FIFO First In First Out to a SRSL Shortest Remaining Shelf Life approach Follow up applications can be potentially expanded to provide for selection and or screening of donors with andquot non storableandquot blood assessing a given unitandapos s suitability for a particular clinical use e g g irradiation or suitability for particular patient groups e g neonatal trauma chronic anemia PUBLIC HEALTH RELEVANCE Proposed project aims to preliminary validate in vitro Red Blood Cell membrane mechanical fragility as a candidate metric predictive of transfusion in vivo efficacy Successful validation could enable a wide range of applications from blood inventory management and triage to personalized matching of units to particular patients for improved efficacy and safety of blood transfusions