More than 5 million U.S. patients take oral anticoagulants daily for the prevention and treatment ofthromboembolic events. Most of them are outpatients in need of frequent at"home monitoring of anticoagulanttherapy. According to the National Action Plan for Adverse Drug Event (ADE) Prevention, anticoagulants are "the mostcommon causes of ADEs across health care settings". 33% of all emergent hospitalizations among older adults are theresult of unintentional anticoagulant overdose. Yet despite these significant problems in anticoagulation therapymanagement, available devices for home"use monitoring of oral anticoagulant therapy are not only poor predictors ofcoagulation status, but also not sensitive to dosage effects of oral anticoagulants. The long"term objective of this SBIR Phase I project is to develop a prototype device for home"use monitoring ofanticoagulant therapy. Levisonics Inc. has developed a unique lab"in"a"drop technology for blood coagulation analysis,referred to as "quasi"static acoustic tweezing thromboelastometry" or QATT. In QATT, temporal changes in clotfirmness are assessed from a single drop of blood (4"6 microliters in volume) levitating in air under the acoustic radiationforce. QATT addresses the issues of home point"of"care coagulation testing through the following disruptive features: 1)small sample volume requirement; 2) increased reliability and accuracy due to non"contact measurement; and 3) rapidassessment of blood coagulation status. The objective of this SBIR proposal will be accomplished in three tasks. First, the existing laboratory researchapparatus will be miniaturized and refined to a form factor suitable for home use (Specific Aim 1), with a simplified userinterface for the target population. Second, a finger"to"device sample delivery method will be implemented (SpecificAim 2) requiring only a single finger"prick drop of blood. Third, the feasibility of the home use prototype developed inSpecific Aim 1 will be established by testing both capillary and venous blood from normal volunteers (Specific Aim 3)exposed to controlled variations of heparin and oral anticoagulant doses.
Public Health Relevance Statement: PROJECT NARRATIVE
Every day millions of people, many of whom are enjoying an active retirement and leading otherwise normal lives,
must take oral medications to control their risk of blood clots due to heart disease or other conditions. However,
because there is no reliable home test to provide current information on their blood clotting status, many of these
patients will require hospitalization because of an unintentional (and avoidable) bleeding incident. The rapid, low"
volume blood coagulation analysis platform developed and validated in this proposal promises to give these patients
and their doctors the assurance that their medication dosage meets their changing needs in the comfort of their home
as frequently as needed.
Project Terms: Acoustics ; Acoustic ; Affect ; Elderly ; advanced age ; elders ; geriatric ; late life ; later life ; older adult ; older person ; senior citizen ; Air ; inhibitor/antagonist ; inhibitor ; Anticoagulants ; Anticoagulant Agents ; Anticoagulant Drugs ; blood thinner ; thrombopoiesis inhibitor ; Anticoagulation ; Atrial Fibrillation ; Auricular Fibrillation ; Blood ; Blood Reticuloendothelial System ; Blood coagulation ; Blood Clotting ; Blood Coagulation Factor ; Coagulation Factors ; clotting factor ; Blood Volume ; Blood capillaries ; capillary ; Cause of Death ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Fibrinogen ; Blood Coagulation Factor I ; Blood Coagulation Factor One ; Blood Factor One ; Coagulation Factor I ; Coagulation Factor One ; Factor I ; Factor One ; Fibrinolysis ; Fibrinolyses ; Fibrinolytic Agents ; Antithrombic Drugs ; Antithrombotic Agents ; Fibrinolytic Drugs ; Thrombolytic Agents ; Thrombolytic Drugs ; Fingers ; Goals ; Healthcare Systems ; Health Care Systems ; Heart Diseases ; Cardiac Diseases ; Cardiac Disorders ; heart disorder ; Heart Valve Diseases ; Valvular Heart Diseases ; Valvular Heart Disorder ; cardiac valve disease ; cardiac valve disorder ; cardiac valvular disease ; degenerative valvular heart disease ; heart valve disorder ; Hemorrhage ; Bleeding ; blood loss ; Hemostatic Agents ; Hemostatics ; Heparin ; Heparinic Acid ; Hospitalization ; Hospital Admission ; Hospitals ; Laboratory Research ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Medicine ; Methods ; Outpatients ; Out-patients ; Overdose ; Activated Partial Thromboplastin Time measurement ; Activated Partial Thromboplastin Time ; Partial Thromboplastin Time ; aPTT ; Patients ; Plasma ; Blood Plasma ; Plasma Serum ; Reticuloendothelial System, Serum, Plasma ; Recurrence ; Recurrent ; Retirement ; Risk ; Target Populations ; Technology ; Testing ; Thromboembolism ; Time ; Veins ; Venous Thrombosis ; Phlebothrombosis ; Warfarin ; Work ; Measures ; Anticoagulant therapy ; Anticoagulant Chemotherapy ; base ; dosage ; Blood specimen ; Blood Sample ; Procedures ; Venous blood sampling ; Phlebotomy ; sample collection ; specimen collection ; Phase ; Variant ; Variation ; Visual ; Individual ; Measurement ; Exposure to ; Venous ; Diagnostic ; Event ; Oral ; Visit ; monitoring device ; Venipunctures ; novel ; Prevention ; Devices ; Reporting ; Coagulation Factor Deficiency ; Radiation ; Sampling ; response ; miniaturize ; Drops ; Clotting ; Coagulation ; Coagulation Process ; Address ; Dose ; Data ; Detection ; Motor ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Update ; Wireless Technology ; wireless ; Monitor ; point of care ; cost ; injured ; older patient ; elderly patient ; Outcome ; innovation ; innovate ; innovative ; volunteer ; healthy volunteer ; prototype ; aging population ; aged population ; population aging ; safety testing ; Adverse drug event ; health care settings ; healthcare settings ; platelet function ; data standards ; data standardization ; home test ; home-based test ; COVID-19 patient ; COVID infected patient ; COVID patient ; COVID positive patient ; COVID-19 infected patient ; COVID-19 positive patient ; COVID19 patient ; COVID19 positive patient ; SARS-CoV-2 infected patient ; SARS-CoV-2 patient ; SARS-CoV-2 positive patient ; coronavirus disease 2019 infected patient ; coronavirus disease 2019 patient ; coronavirus disease 2019 positive patient ; coronavirus disease infected patient ; coronavirus disease patient ; coronavirus disease positive patient ; coronavirus patient ; patient infected with COVID ; patient infected with COVID-19 ; patient infected with SARS-CoV-2 ; patient infected with coronavirus disease ; patient infected with coronavirus disease 2019 ; patient infected with severe acute respiratory syndrome coronavirus 2 ; patient with COVID ; patient with COVID-19 ; patient with COVID19 ; patient with SARS-CoV-2 ; patient with coronavirus disease ; patient with coronavirus disease 2019 ; patient with severe acute respiratory distress syndrome coronavirus 2 ; severe acute respiratory syndrome coronavirus 2 infected patient ; severe acute respiratory syndrome coronavirus 2 patient ; severe acute respiratory syndrome coronavirus 2 positive patient ; Home ;
