Performance Evaluation of a Coagulation Monitoring System
Research type
Research Study
Full title
Performance Evaluation of a Point of Care Coagulation Monitoring System in an intended use setting.
IRAS ID
208422
Contact name
Andrew Rushton
Contact email
Sponsor organisation
MedtechToMarket LTD
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
This is a prospective observational study to evaluate the performance of a Point of Care Coagulation Monitoring (PCM) System in the intended use setting.\nThe primary objective of this study is to evaluate the performance of the PCM System against an established test method - this will be achieved by comparing five coagulation parameters measured by the two systems.\nThe secondary objective is to evaluate the ability of the PCM System to quantify Clot Lysis in comparison to an established test method.\nThe PCM System needs to be validated with blood samples representing a range of coagulation states; specific patient groups will be selected:\n•\tPatients with planned Major Abdominal Surgery\n•\tMajor Orthopaedic Surgery as proxies for trauma patients\n•\tPatients with planned Vascular Surgery\nPatients who have been fully informed, provide written informed consent and who meet the eligibility criteria will be recruited into the study.\nParticipants will donate blood samples immediately before and once during planned surgery; each donation will consist of 10 ml of blood (20mL of blood in total).\nThe blood samples will be run on the PCM System and the established test method (ROTEM® NATEM test) and the results compared.\nThe results will be used to validate the performance of the PCM system for CE Marking purposes.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0655
Date of REC Opinion
4 Oct 2016
REC opinion
Further Information Favourable Opinion