Point of Care Thromboelastogram Device Development
Research type
Research Study
Full title
Blood Donation for the Bench development of a Point of Care Thromboelastogram Device
IRAS ID
161255
Contact name
Richard Fitzgerald
Contact email
Eudract number
n/a
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
This study is to develop and test the technology for measuring the efficiency of blood coagulation ( reaction time, speed of clotting and clot strength) , which is important for controlling bleeding during surgery or major trauma involving potential major blood loss. Fresh whole blood is required to develop the test , hence this study which is designed to provide samples of fresh whole blood from three groups of volunteers expected to have different blood clotting characteristics, thus enabling a range of clotting types to be tested. Samples of 5ml will be taken from each subject, put on ice and transferred to the sponsor laboratory where it will tested using the current standard test (ROTEM) and split into smaller samples for development and testing of the new technology.
Once set up, the system will be assessed in terms of accuracy, precision, stability and robustness. Precision will be tested in part by inviting a number of healthy volunteers to return for a second blood sample within 20 days of the first.
The technology is specifically intended for a point of care portable device and will eventually comprise an instrument and associated blood sample test cartridge. Information generated from testing will be used to design a prototype system.REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/1179
Date of REC Opinion
2 Oct 2014
REC opinion
Favourable Opinion