SBIR-STTR Award

Over 60% of the 600,000 patients undergoing cardio-pulmonary bypass (CPB) procedures in the US each year experience intra- and post-operative bleeding. Treatment options are available, each corresponding to a specific hemostatic defect: (a) fresh frozen plasma (FFP) to correct the plasma coagulation proteins, (b) platelet concentrate to restore platelets, (c) cryoprecipitate to restore fibrinogen, and (d) antifibrinolytics to slow the activity of the clot-dissolving proteins. However, clinical evidence strongly indicates that targeted use of these products can reduce mortality by 2.5X, myocardial infarction by 3X, renal failure by 13X, and stroke events by 3.6X, while producing savings of up to $4M/year per hospital. Unfortunately, there is no global test of hemostasis available at the point of care (POC), which is able to provide rapid results about the best treatment option. The tests that are available at POC can't provide the required information, even if used in combination. Thus, current clinical practice is iterative transfusion of blood products and subjective evaluation of bleeding. This process is slow and prone to over transfusions, resulting in increased risk of immunological reactions, infections, and unnecessary expenses. Proposed Solution: HemoSonics LLC is developing a POC instrument, the HemoSonics Global Hemostasis Analyzer (HS-GHA) that can directly quantify the function of the four hemostatic components, enabling appropriate selection of treatment. The HS-GHA is based on sonorheometry (SR), a novel ultrasound-based technology able to assess not only time to clot (dependent upon the plasma coagulation proteins) but also clot formation rate (dependent upon fibrinogen), clot stiffness (dependent upon fibrinogen and platelets), and time to lysis (dependent upon clot-dissolving proteins). If proven successful, the HS-GHA will help: (i) the surgical team administer the correct treatment, (ii) the hospital save costs by reducing unnecessary transfusions, (iii) the blood bank save blood products, and (iv) improve patient's care. Feasibility of this approach will be established if it is demonstrated that SR can measure the function of the 4 components of hemostasis. This research is a collaborative effort between HemoSonics, LLC and the University of Virginia Department of Biomedical Engineering and School of Medicine. , ,

Public Health Relevance:
Clinical evidence strongly indicates that improved management of bleeding with targeted use of blood products can reduce one-year mortality by 2.5X, myocardial infarction by 3X, renal failure by 13X, and stroke events by 3.6X, while producing cost savings of up to $4M/year per hospital. Unfortunately, management of bleeding remains suboptimal due to the limitations of current diagnostic tests. The goal of this proposal is to develop a novel point-of-care (POC) diagnostic instrument that will improve the current management of bleeding and usage of blood products, thus improving patients'outcomes and generating substantial cost savings.

Thesaurus Terms:
2-(Acetyloxy)Benzoic Acid;Acetylsalicylic Acid;Address;Anti-Inflammatories;Anti-Inflammatory Agents;Anti-Inflammatory;Antifibrinolysins;Antifibrinolytic Agents;Antifibrinolytics;Antiinflammatories;Antiinflammatory Agents;Apoplexy;Aspergum;Aspirin;Biomedical Engineering;Bizzozero's Corpuscle/Cell;Bleeding;Blood;Blood Banks;Blood Clot;Blood Clotting;Blood Coagulation Factor I;Blood Coagulation Factor One;Blood Factor One;Blood Plasma;Blood Platelet Count;Blood Platelet Number;Blood Platelets;Blood Coagulation;Bypass;Cardiac Infarction;Care, Health;Cerebral Stroke;Cerebrovascular Apoplexy;Cerebrovascular Stroke;Cerebrovascular Accident;Clinical;Clinical Research;Clinical Study;Clotting;Coagulation;Coagulation Factor I;Coagulation Factor One;Coagulation Process;Comment;Comment (Pt);Comment [publication Type];Commentary;Commentary (Pt);Cost Savings;Cytolysis;Data;Deetjeen's Body;Defect;Development;Diagnosis, Ultrasound;Diagnostic Tests;Disabled Persons;Disabled Population;Dose;Drugs;Dysfunction;Echography;Echotomography;Ecotrin;Editorial Comment;Editorial Comment (Pt);Empirin;Entericin;Evaluation;Event;Exhibits;Extren;Factor I;Factor One;Ferrate(2-), (7,12-Diethenyl-3,8,13,17-Tetramethyl-21h,23h-Porphine-2,18-Dipropanoato(4-)-N21,N22,N23,N24)-, Dihydrogen, (Sp-4-2)-;Ferroprotoporphyrin;Fibrinogen;Fresh Frozen Plasmas;Functional Disorder;Goals;Hosp;Handicapped;Hayem's Elementary Corpuscle;Healthcare;Heme;Heme B;Hemorrhage;Hemostasis;Hemostatic Agents;Hemostatic Function;Hemostatics;Hospitals;In Vitro;Infection;Kidney Failure;Kidney Insufficiency;Laboratories;Lead;Lung;Lysis;Marrow Platelet;Measurement;Measures;Measurin;Medical Imaging, Ultrasound;Medication;Methods;Mortality;Mortality Vital Statistics;Myocardial Infarct;Myocardial Infarction;Normal Range;Normal Values;Operation;Operative Procedures;Operative Surgical Procedures;Outcome;Patient Care;Patient Care Delivery;Patients;Pb Element;People With Disabilities;Performance;Persons With Disabilities;Pharmaceutic Preparations;Pharmaceutical Preparations;Phase;Physiopathology;Pilot Projects;Plasma;Platelet Count;Platelet Count Measurement;Platelet Number;Platelets;Plavix;Post-Operative;Postoperative;Postoperative Period;Procedures;Process;Proteins;Protoheme;Protoheme Ix;Published Comment;Reaction;Reference Ranges;Reference Values;Renal Failure;Renal Insufficiency;Reproducibility;Research;Respiratory System, Lung;Reticuloendothelial System, Blood;Reticuloendothelial System, Platelets;Reticuloendothelial System, Serum, Plasma;Risk;Sbir;Sbirs (R43/44);Sampling;Saving, Cost;Savings;Selection For Treatments;Serum, Plasma;Small Business Innovation Research;Small Business Innovation Research Grant;Solutions;Stroke;Structural Protein;Surgical;Surgical Interventions;Surgical Procedure;Trnsf;Technology;Testing;Thrombocytes;Time;Transfusion;Ultrasonic Imaging;Ultrasonogram;Ultrasonography;Ultrasound Test;Ultrasound, Medical;Universities;Variant;Variation;Vascular Accident, Brain;Viewpoint;Viewpoint (Pt);Virginia;Work;Base;Bioengineering;Bioengineering/Biomedical Engineering;Blood Loss;Blood Product;Brain Attack;Cardiac Infarct;Cerebral Vascular Accident;Clinical Practice;Clopidogrel;Coronary Attack;Coronary Infarct;Coronary Infarction;Cost;Diagnostic Ultrasound;Disabled;Disabled People;Drug/Agent;Experience;Experiment;Experimental Research;Experimental Study;Ferroheme;Gene Product;Healthy Volunteer;Heart Attack;Heart Infarct;Heart Infarction;Heavy Metal Pb;Heavy Metal Lead;Improved;Innovate;Innovation;Innovative;Instrument;Medical Schools;Novel;Pathophysiology;Pilot Study;Point Of Care;Point-Of-Care Diagnostics;Prototype;Public Health Relevance;Pulmonary;Research Study;Response;Sonogram;Sonography;Sound Measurement;Stroke;Surgery;Thrombocyte/Platelet;Ultrasound;Ultrasound Imaging;Ultrasound Scanning

The Problem: Over 60% of the 600,000 patients undergoing cardio-pulmonary bypass (CPB) procedures in the US each year experience excessive bleeding, which requires transfusions of blood products. There are four treatment options available, each corresponding to a specific hemostatic defect: (a) fresh frozen plasma (FFP) to correct the plasma coagulation factors, (b) platelet concentrate to restore platelets, (c) cryoprecipitate to restore fibrinogen, and (d) anti-fibrinolytics to slow the activity of the clot-dissolving proteins. However, clinical literature strongly indicates that morbidity and mortality risks increase in a dose-dependent way with increased use of blood products. It has been estimated that each unit transfused increases the post-operative odds of severe infection by 76%, cardiac morbidity by 55%, neurological morbidity by 39%, and overall in- hospital mortality by 77%. Furthermore post-operative length of stay increases by 0.82 days per unit transfused. Meanwhile, targeted use of these products can produce savings of up to $4M/year per hospital. Unfortunately, there is no global test of hemostasis available at the point of care (POC), which is able to provide rapid results about the best treatment option. The tests that are available at POC can't provide the required information, even if used in combination. Thus, current clinical practice is iterative transfusion of blood products and subjective evaluation of bleeding. This process is slow and prone to over transfusions, resulting in increased risk of worsened outcomes and unnecessary expenses. HemoSonics' Proposed Solution: HemoSonics LLC is developing a POC instrument, the Global Hemostasis Analyzer (GHA) that can quantify the function of the four hemostatic components, enabling correct selection of treatment. The GHA is based on sonorheometry (SR), a novel technology able to assess not only time to clot (dependent upon the plasma coagulation factors) but also clot formation rate (dependent upon fibrinogen), clot stiffness (dependent upon fibrinogen and platelets), and time to lysis (dependent upon clot-dissolving proteins). The GHA will help: (i) the surgical team administer the correct treatment, (ii) the hospital save costs by reducing unnecessary transfusions, (iii) the blood bank save blood products, and, most importantly, (iv) improve patient care. Proposed SBIR Work: In Phase I, we successfully completed demonstration of the feasibility of SR to measure the function of the four hemostatic components. In Phase II, we intend to finalize prototype development and evaluate its performance in CPB, in order to test the hypothesis that SR can provide information that will aid in minimizing unnecessary transfusions, reducing overall healthcare spending and improving patient outcomes. Furthermore, data obtained in these studies will be utilized for FDA regulatory approval. This research is a collaborative effort between HemoSonics, the University of Virginia Department of Biomedical Engineering and School of Medicine, and Medical College of Virginia (Virginia Commonwealth University).

Public Health Relevance Statement:


Public Health Relevance:
Clinical evidence strongly indicates that improved management of bleeding with targeted use of blood products can reduce morbidity and mortality risks while producing significant cost savings. It has been estimated that each unit of blood products transfused increases the post-operative odds of severe infection by 76%, cardiac morbidity by 55%, neurological morbidity by 39% and overall in-hospital mortality by 77%. Post-operative length of stay also increases by 0.82 days per unit transfused. Meanwhile, targeted use of these products can produce savings of up to $4M/year per hospital. Unfortunately, management of bleeding remains suboptimal due to the limitations of current diagnostic tests. The goal of this proposal is to develop a novel point-of-care (POC) diagnostic instrument that will improve the current management of bleeding and usage of blood products, thus improving patients' outcomes and generating substantial cost savings.

Project Terms:
Area Under Curve; base; Biomedical Engineering; Blood; Blood Banks; Blood Coagulation Factor; Blood Platelets; blood product; Bypass; Cardiac; Clinical; clinical practice; Clinical Research; Coagulation Process; cost; Cost Savings; Cytolysis; Data; Defect; Development; Devices; Diagnostic tests; Dose; Drainage procedure; Evaluation; experience; Fibrinogen; Fibrinolysis; Fresh Frozen Plasmas; Goals; Healthcare; Hematocrit procedure; Hemorrhage; Hemostatic Agents; Hemostatic function; Hospital Mortality; Hospitals; Hour; Human Resources; improved; Infection; instrument; Length of Stay; Literature; Lung; Measurement; Measures; medical schools; Morbidity - disease rate; Mortality Vital Statistics; Neurologic; new technology; novel; Operative Surgical Procedures; Outcome; Output; Patient Care; Patients; Performance; Phase; Plasma; point of care; point-of-care diagnostics; Postoperative Period; Preparation; Procedures; Process; prospective; Proteins; prototype; public health relevance; Reagent; Reference Values; Reproducibility; Research; research clinical testing; Risk; Savings; Selection for Treatments; Site; Small Business Innovation Research Grant; Solutions; Specificity; Test Result; Testing; Time; time interval; Training; Transfusion; Tube; Universities; Virginia; Work