CoaguScan CPS-HV
Research type
Research Study
Full title
Clinical Performance Study Establishing Reference Intervals for CoaguScan System
IRAS ID
322939
Contact name
Mansoor Ali Khan
Contact email
Sponsor organisation
Highland Biosciences Limited
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Trauma teams work to stabilize the vital functions of patients who have experienced major trauma, often including severe bleeding. Severe bleeding can surprisingly impact patients differently: for many patients, replacement of fluids is sufficient to stabilise them, but for a significant number the blood loss itself can affect the way blood starts to clot and can lead to a spiral of further loss and other complications called Coagulopathy. Clinicians have treatments available but need to identify Coagulopathic patients quickly (every minute counts), then carefully monitor them.
A diagnostic test already exists that can help a clinician identify Coagulopathy in a patient blood sample but it is only used by about a third of trauma teams in the UK. A key problem with the current test is the result may not come back to the clinician in time for them to take it into account when making a treatment decision.
The device under investigation (CoaguScan) seeks to solve this by simplifying the test process and allowing the test to be run at the patients’ bedside, eliminating the processing time and allowing the clinician to see the results develop in real-time.
This study is to determine a set of values that a blood sample from a normal healthy person would display on this new device so that a clinician can compare them to the patient blood sample: if a value is outside the expected range for a healthy person, it indicates the clinician should consider whether the patient is Coagulopathic. The study will take place in a clinical studies facility where healthy volunteers will be invited to provide a small blood specimen taken from the arm. A specimen will only be taken once per volunteer and the study will be complete once enough specimens have been collected.
REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0921
Date of REC Opinion
1 Feb 2023
REC opinion
Further Information Favourable Opinion