Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)
NCT ID: NCT03682419
Last Updated: 2019-02-27
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
NA
420 participants
INTERVENTIONAL
2018-09-17
2018-11-23
Brief Summary
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Detailed Description
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The accuracy of the LumiraDx Instrument INR results will be assessed by, in the first instance, comparison to the INR results obtained from the same individuals as analysed by trained laboratory professionals using the paired venous plasma samples in the reference device IL ACL ELITE PRO Coagulation Analyzer. The accuracy of INR measurements of capillary whole blood across the range of haematocrit (25% - 55%) will be assessed using paired haematocrit results obtained from the HemoCue Hb 201+ on venous whole blood. The results of these evaluations are intended to be used for regulatory filings for the LumiraDx Instrument and LumiraDx INR test as an in vitro diagnostic test in the European Union (EU) and other relevant geographies. For information only, the accuracy of the LumiraDx Instrument INR Test will also be assessed by comparison to INR results from an alternative point of care instrument, the Roche Coaguchek PRO II.
Adult males and females currently in receipt of vitamin K antagonist therapy will be included on the study. Approximately 500 subjects will be recruited to ensure that sufficient suitable subjects are enrolled and to allow for a small level of exclusions. The power calculation as well as recommendations of the FDA CLIA Waiver Guidance document (1) requires a minimum of 360 valid subjects in total (inclusive of non-therapy subset). A subsection of the subject population (\~50 subjects) will consist of adult males and females who fulfil all other study inclusion criteria but are not in receipt of vitamin K antagonist therapy. This will be done in order to test the lower measurement limit of the LumiraDx Instrument INR test. At the end of the study the Healthcare Professional will be asked to complete a User Acceptability Questionnaire which is intended to assess the acceptability of the LumiraDx INR system in terms of ease of use.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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VKA Patients
Single Arm - blood collection by venepuncture and fingerstick in patients undergoing Warfarin Therapy
VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Non-VKA Patients
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
non-Vka Patients
Single Arm - blood collection by venepuncture and fingerstick in patients not undergoing Warfarin Therapy
VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Non-VKA Patients
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Interventions
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VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Non-VKA Patients
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent and comply with study procedures
* Currently prescribed vitamin K antagonist therapy
* Deemed medically appropriate for study participation by the Investigator
* Persons \>18 years of age
* Willing and able to provide written informed consent and comply with study procedures
* Deemed medically appropriate for study participation by the Investigator
Exclusion Criteria
* Subject has previously participated in this study
* Subject is within 4 weeks of first prescription of vitamin K antagonist therapy
* Confirmed or suspected pregnancy
* Unwilling or unable to provide written informed consent and comply with study procedures
* Vulnerable populations deemed inappropriate for study by the Investigator
* Deemed medically inappropriate for study by the Investigator (i.e. patients with a known inherited \[e.g. haemophilia or von Willebrand's disease\] or acquired \[e.g. liver cirrhosis\] condition likely to be associated with a coagulopathy; or patients receiving non-VKA anticoagulant medications)
* Persons \<18 years of age
* Subject has previously participated in this study
* Confirmed or suspected pregnancy
* Unwilling or unable to provide written informed consent and comply with study procedures
* Vulnerable populations deemed inappropriate for study by the Investigator
* Any persons deemed medically inappropriate for study by the Investigator
18 Years
ALL
No
Sponsors
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LumiraDx UK Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Robert C Tait, BSc (Hons)
Role: PRINCIPAL_INVESTIGATOR
Consultant Haematologist
Locations
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Glasgow Royal Infirmary Clinical Research Facility
Glasgow, , United Kingdom
Golden Jubilee National Hospital
Glasgow, , United Kingdom
Wishaw General Hospital, NHS Lanarkshire
Wishaw, , United Kingdom
Countries
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References
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Tait RC, Hung A, Gardner RS. Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619890423. doi: 10.1177/1076029619890423.
Other Identifiers
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D-CLIN-PROT-00001
Identifier Type: -
Identifier Source: org_study_id
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