Development of a Novel Point-of-Care Device for RapidStratification and Management of Brain Injury

The unmet need to be addressed Platelet management is critical for brain injury patients, either because of a trauma or a cardiovascular condition (e.g. stroke). This is important not only to minimise bleeding but also for other reasons such as controlling inflammation or maintaining the blood barrier integrity [1]. One of the main treatment challenge is to manage the bleeding and clotting risk at the same time, while there are point-of-care (POC) devices to assess haemostasis (like thromboelastogram) or to check the response to antiplatelet therapy (such as Verify now) in an acute setting (A&E triage or surgery theatre), there is no rapid POC platelet counters to support rapid clinical decisions (e.g. platelet transfusion), hence there is a need to supplement actual POCs for enhanced monitoring and treatment guidance, and eventually replace them with a "3-in-1" solution [2, 3, 4]. Here we proposed to test the usability of Beyond Blood Diagnostics (BBD) microfluidic flow-cytometer for the measurement of platelet counts and of the whole haemostatic/clotting function (i.e. both aggregation and clotting pathway [5]) to handle the initial triage and then offer critical treatment guidance throughout the patient care journey. Proof-of-concept and additional evidence in place and how will it be further explored BBD has patented a flow-cytometry microfluidic for blood cell counts analysis. Proof-of-Concept studies showed successful isolation of cells using their properties under flow, sorting them into different channels and identifying them by tracing their unique electronic signature. While all blood cells can be identified, studies so far were focussed on neutrophil and red blood cells. We want to redesign our device and analyse the signal to generate Proof-of-Concept data to assess if our technology can sort and detect platelets in a useful way for the management of brain injury. While Current technology allows platelet counting, in the context of brain injury there is also a need of accessing the haemostatic/clotting function. Recent publications [2, 3] have demonstrated the potential of microfluidic cytometer with impedance captor not only for platelet counts but also evaluating the haemostatic function from low platelet count or thrombocytopenic blood and anti-platelet drug monitoring, which is one of the limitations of current technologies. With some adaptations of our device on the microfluidic part we should be able also to evaluate the haemostasis. PPI activities conducted to date No formal PPIE has been conducted as we intend to conduct here the first usability study for platelet functionalities of our microfluidic device. However, having spoken to clinicians (Dr John Luckit, Haematologist and Dr Andrew Alalade, Neurosurgeon), we had confirmation of our literature findings [2, 3, 4, 6, 7]. There is a need for a rapid platelet counter POC device in an A&E and surgical setting, that could benefit from other functions (haemostatic/clotting and antiplatelet drug response). Even if not directly related, we had conducted PPIE studies for the use of our technology to manage neutropenia in cancer patients showing its importance in a community setting.