CoagCare: Hand-Held, Point-of-Care Thromboelastography Blood Diagnostic Platform to Screen for COVID-19-Associated Coagulopathy
Abstract
This proposed project is related to the FY20 PRMRP Topic Areas of “Emerging Viral Diseases” with a focus on “Triage of care for coronavirus disease 2019 (COVID-19) patients requiring access to resource-intensive interventions,” and “Respiratory Health” with a focus on “Development of biomarker metrics to associate the long-term health outcomes of virus-induced acute respiratory distress syndrome (ARDS) with degradation of physiological and physical performance.” The project is focused on developing a novel blood diagnostic platform that can be used for early screening of COVID-19-related blood clotting disorders in hospitals and clinics. The system will provide crucial diagnostic information to triage or prioritize care for COVID-19 patients by identifying the type and extent of these clotting disorders and help predict long-term health outcomes of the disease. The system will be similar to a hand-held glucose meter and strip system and provide a low-cost and robust solution suitable for portable use. Background and Rationale: Since the December 2019 outbreak of the COVID-19 pandemic in Wuhan, China, there have been over 7.5 million confirmed cases worldwide with a death rate of ~6%. COVID-19 patients demonstrate a high number of blood clotting disorders, which is the major cause of death in patients with severe disease. In the past month, this clotting disorder has resulted in a high number of adverse events (e.g., stroke), both in patients who have symptoms and those who don’t, due to the generation of unwanted clots traveling to different organs (e.g., brain). Based on multiple clinical findings, it has been reported that these clots appear to be stiffer than normal. Further, it was found that tiny versions of these stiff clots form in the lungs leading to difficulty breathing (requiring a ventilator to help the patient breathe), whereas bigger versions circulate in the blood stream causing multiple types of adverse events. Once these clots are formed, blood thinners and other transfusions are crucially needed both in the hospital and after discharge to ensure survival. With the growing hospital burden for managing COVID-19 patients, there is an urgent need for diagnostic testing to detect this blood clotting disorder early and predict the severity of the disease in order to triage or prioritize care accordingly. Unmet Need: Physicians and surgeons who managed the first wave of COVID-19 patients in Wuhan specifically recommend the routine use of the thromboelastography (TEG) test, which monitors blood clot stiffness, in order to diagnose and manage this blood clotting disorder. Further, multiple clinical studies have since demonstrated the high accuracy with which these tests can diagnose this clotting disorder, in addition to helping tailor blood thinner dosage to manage this condition. Unfortunately, current TEG test systems are bulky (1 cubic foot and 10 pounds), laborious, very sensitive to vibrations, and require up to 30-60 minutes for a complete measurement – far too complex and slow for effective management during a pandemic. There is an urgent need for a hand-portable diagnostic system with fast result times for early screening and management of this blood clotting disorder in hospitals, ambulances, and clinics. Objectives and Specific Aims: The objectives of this proposed work are to develop a product and demonstrate the clinical utility of a blood diagnostic TEG test system (CoagCare), comprised of plastic-laminated test strips that interface with a hand-portable, wireless meter (similar to a glucose meter), to detect abnormal clot stiffness in < 5-10 minutes in COVID-19 patient blood samples. Listed below are the specific aims for the project: 1. Product development of CoagCare system (includes prototyping, manufacturing and testing). 2. Regulatory Submissions (includes Food and Drug Administration (FDA) emergency use approval (EUA)) 3. Product Verification Studies (includes product
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110013
Entities
People
- Ramkumar Abhishek
Organizations
- United States Army