a clinical study to deFine Precision, accuracy and cOmparabIlity of results from a Novel poinT of care fibrinogen assay compared to an industry standard
Principal Investigator – Dr. Patrick Thornton
This research study is taking place to find out how well a new bedside medical device measures the level of a clotting component in the blood and comparing it to the current standard in the laboratory. The component in the blood we are measuring is called Fibrinogen and it is important to know how much of it there is in the blood especially if someone is bleeding.
Currently this blood component is measured by taking a blood sample and sending it to the laboratory to be measured. It normally takes about 20-30 minutes to get a result using this way. This is time consuming, and workload intensive for laboratory staff. This has effects in terms of getting a test result quickly so we as doctors can make decisions on how to treat patients who are bleeding.
A bedside test (like the one we are testing) with more rapidly available results at the bedside should help improve the speed of getting a result and help us make decisions on treatment faster. The aim therefore is to test and compare this device and see how well and closely it measures the fibrinogen level compared to our standard laboratory test. Blood drawn from consented patients are to be run on the F-Point device and the standard device to ensure the results are accurate on the F-Point device.