An observational study in Critical Care and Child, sponsored by University of Leeds. Completed at 1 site in United Kingdom. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2021-02-09.
Sponsored by University of Leeds · Observational
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).
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 the investigators need to compare both forms of testing in the following areas:
University of Leeds is the lead sponsor of 200 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to Paediatric Intensive Care Unit under the age of 16 years
Exclusion Criteria:
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Bedside test of Activated Partial Thromboplastin Time
Accuracy of APTT result (measured in seconds) provided by Hemochron Signature Elite compared to standard laboratory APTT value as gold standard (measured in seconds) on paired samples, using Pearson Correlation
APTT measured on fresh whole blood using Hemochron Signature Elite, the device converts this to a plasma equivalent value for clinical use, reported in seconds. The gold standard laboratory assay in our Trust uses ACL Top 750 Analyser, with APTT reported in seconds. Pearson Correlation Co-efficient will be used to determine level of agreement.
Time frame: 6 hours
Mean time efficiency of Hemochron Signature Elite to provide APTT result (measured in minutes till APTT result being available), compared to the mean time taken (in minutes) for the standard laboratory measure of APTT result to become available.
Investigators will calculate the mean time difference between results being obtained using Hemochron Signature Elite point of care (bedside) testing using the time recorded on the data collection sheet and comparing this with the mean time the results were released by the standard hospital laboratory which is stated on the hospital results server. The laboratory staff will be blinded to ensure the timings are a genuine reflection of standard care within the hospital. Time taken for each method of APTT measurement will be measured from the moment the samples are obtained from participants until the result becomes available. Mean time taken by each method across all participants will be compared.
Time frame: 6 hours
Cost effectiveness (in £ GBP) of Hemochron Signature Elite point of care APTT testing compared to standard laboratory measurement of APTT. This will be reported as overall mean cost (in £ GBP) to provide 1 APTT result using each system, for comparison.
Costs will be determined by combining the fixed costs such as the costs of analyzers, quality control testing, cuvettes and sampling equipment with the variable costs such as utilisation of porters to transport samples when the air-tube system is not working. Costs related to the Hemochron Signature Elite will be as per the manufacturer's price list. The cost of routine laboratory testing will be obtained from the Hospital pathology services management team
Time frame: 1 day
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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University of Leeds