A comparison of laboratory versus point-of care (bedside) APTT testing
Research type
Research Study
Full title
A comparison of laboratory APTT testing versus point-of care (bedside) Activated Partial Thromboplastin Time (APTT) testing in the Paediatric Intensive Care Population: An assessment of accuracy, time efficiency and cost-effectiveness.
IRAS ID
239600
Contact name
Timothy William Rayner Lee
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
The overall aim of the study is to determine whether point-of-care (bedside) Activated Partial Thromboplastin Time (APTT) testing would be better than laboratory APTT testing in the PICU population (restricted to children under 16 years of age). To do this we need to compare both forms of testing in the following areas:\n\n1)\tAccuracy – using laboratory results as our control we want to ascertain how reliable Point-of-care (bedside) testing with the Hemochron Signature Elite is by comparing paired samples. The Hemochron Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests, including APTT, on fresh or citrated whole blood. The Hemochron Signature Elite instrument is CE marked and complies with multiple safety standard requirements and directives. We know that the Hemochron Signature Elite is not 100% accurate compared to the laboratory but the degree of inaccuracy, particularly in the paediatric population is not clear, if within acceptable & predictable limits we would still be able to use this in clinical practice.\n2)\tTime efficiency – in view of the fact the Hemochron Signature Elite is on PICU, results from this will be almost immediately available. We then want to measure exactly how long it takes from the moment the laboratory sample is taken for the results to be available.\n3)\tCost-effectiveness – we want to compare the costs of these two types of testing in detail, including costs for the Hemochron Signature Elite machine, Hemochron Signature Elite cuvettes, laboratory Clotting Screen bottles, laboratory Clotting Screen analysis, and maintaining the two different types of equipment. We will also take into account any other regular costs (e.g. porters to take samples to the laboratory when the pod system is down). We plan on seeking assistance from senior Paediatric colleagues with more experience of health economics in doing a costs minimisation analysis.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0405
Date of REC Opinion
15 Feb 2019
REC opinion
Further Information Favourable Opinion