A Comparison of Laboratory Versus Point of Care (Bedside) APTT Testing
NCT ID: NCT04744701
Last Updated: 2021-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
48 participants
OBSERVATIONAL
2020-02-10
2020-04-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Hemochron Signature Elite Whole Blood Microcoagulation System
Bedside test of Activated Partial Thromboplastin Time
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
15 Years
ALL
No
Sponsors
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University of Leeds
OTHER
Responsible Party
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Dr Tim Lee
Consultant in Paediatric Respiratory Medicine
Principal Investigators
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Tim Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Leeds Children's Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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Other Identifiers
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239600
Identifier Type: -
Identifier Source: org_study_id
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