Clinical trial NCT04744701: A Comparison of Laboratory Versus Point of Care (Bedside) APTT Testing
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Child
Keywords: Thromboplastin
Lead sponsor: University of Leeds
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 48
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Paediatric Intensive Care Unit under the age of 16 years

Brief 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).

Detailed description: 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:

1. Accuracy - using laboratory results as our control the investigators 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. The investigators 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 the investigators would still be able to use this in clinical practice.
2. Time efficiency - in view of the fact the Hemochron Signature Elite is on PICU, results from this will be almost immediately available. The investigators then want to measure exactly how long it takes from the moment the laboratory sample is taken for the results to be available.
3. Cost-effectiveness - the investigators 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. The investigators will also take into account any other regular costs (e.g. porters to take samples to the laboratory when the pod system is down). The investigators plan on seeking assistance from senior paediatric colleagues with more experience of health economics in doing a costs minimisation analysis

Eligibility criteria: Inclusion Criteria:

* Patients admitted to Paediatric Intensive Care Unit under the age of 16 years

Exclusion Criteria:

-

Primary outcomes:
measure: 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
timeFrame: 6 hours
Secondary outcomes:
measure: 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.
timeFrame: 6 hours
measure: 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.
timeFrame: 1 day
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Children's Hospital
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Tim Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: