A hand-held coagulation diagnostic
Case Study – HIGHLAND BIOSCIENCES LTD
Patients that suffer major trauma, for example through road traffic accidents, experience unpredictable changes in their ability to form blood clots meaning that a single therapeutic approach does not control bleeding in all patients. Viscoelastic coagulation diagnostic tests exist to support the surgeon: these identify patients who would benefit from a transfusion against those who are better served by coagulation promoting drugs. The very latest equipment available is complex to use and bulky, needing to be sited in a temperature and vibration controlled area. It is not practical to deliver these diagnostics directly at the point of need in most cases, and for that reason is not widely used. A hand-held coagulation diagnostic could drastically improve patient care. Highland Biosciences believes the detection technology it has developed is suited to hand-held use, being robust, miniature and can be used in the emergency department before the patient reaches surgery, whilst matching the sensitivity of the current diagnostic tests.
Need for a better diagnostic test
Uncontrolled bleeding can be fatal: globally 2.5M/annum deaths. 100K/annum patients in England are affected in trauma and intensive care unit, when it occurs a “code red” is raised and blood and products arrive from the blood bank; up to 20 specialist staff (including vascular and neurological surgeons and anaesthetists) are sent to the patient. Where coagulopathy is suspected a viscoelastometric test (TEG or ROTEM – market $1.5Bn) is run to guide the best course of haemostasis treatment specific to that patient: a staff member takes sample away to test. Often the patient has moved to theatre or intensive unit by the time results are ready: staff have to find the patient to deliver the results. In trauma, a specialist technician is sent with the sample, in intensive units often a junior doctor has to leave the patients’ side to take the sample to the device in a different department – operating theatre. Often the person who interprets the test is in a different department to the person that runs the test: a disjointed route for the flow of information. TEG experts cite 30% test failure rate and suggest analysis of results best performed in the “context” of the patient.
Clinicians want results in 15 minutes: facilitating patient-specific treatment decisions and monitoring the response to treatments administered. Coagulopathy is transient, repeated tests can indicate response to treatment: but tests are of limited value with a 3-hour results turnaround. Without information, clinicians increase the use of blood and products: scarce resources that expose the patient to risk of complications.
Our Work with Highland Biosciences
With funds won from Innovate UK, DEC London generated evidence that supported Highland Bioscience Ltd in developing their POCT device (CoaguScan) which supports the diagnosis, management and monitoring of coagulopathy. The evidence was used to redesign CoaguScan and this research was used to support the (successful) application for a new SBRI phase I project, and will be used to apply for the second phase of SBRI funding. Several peer-reviewed articles are being drafted to disseminate key study findings.
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- Initial concept
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- Final prototype
Funding application
Research was found by the phase I of SBRI and Innovate UK “stratified medicine: connecting the UK infrastructure”. The successful outcomes of phase one have convinced NIHR DEC London and Highland Bioscience to apply for a phase 2 project (up to £2M).
Concurrently another phase I of SBRI for acute medicine was granted Highland Bioscience and NIHR DEC to further support the development of the device in acute pathways.
Impact
CoaguScan can facilitate the workflow of clinicians, and provide quick and reliable results close to the patients. The new device is less expensive, able to depict key factors of coagulopathy currently not available in the field, and able to be applied in different pathways within and outside of the hospital. CoaguScan can extensively benefit patients providing a more accurate set of results and benefit healthcare system with a tool which is less error prone and less expensive.
Infographich summary of the human factors review carried out in Phase 1