Atrial Fibrillation Clinical Trial
— OPTIMALOfficial title:
Evaluation of the Precision and Accuracy of International Normalised Ratio (INR) Measurements as Assessed by the LumiraDx Instrument in a Professional Point of Care Setting With Multiple Operators
Verified date | September 2018 |
Source | LumiraDx UK Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression analysis and other analytical methods.
Status | Completed |
Enrollment | 420 |
Est. completion date | November 23, 2018 |
Est. primary completion date | November 23, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - VKA Therapy Subjects: - Persons >18 years of age - 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 Exclusion Criteria - VKA Therapy Subjects: - Persons <18 years of age - 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) Inclusion Criteria - Non-VKA Therapy Subjects: - 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 - Non-VKA Therapy Subjects: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Glasgow Royal Infirmary Clinical Research Facility | Glasgow | |
United Kingdom | Golden Jubilee National Hospital | Glasgow | |
United Kingdom | Wishaw General Hospital, NHS Lanarkshire | Wishaw |
Lead Sponsor | Collaborator |
---|---|
LumiraDx UK Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the clinical performance of the LumiraDx instrument | Measurement of INR using Capillary & Venous blood samples | 8 weeks | |
Secondary | To determine the accuracy of the LumiraDx instrument | Measurement of INR & Haematocrit using Capillary & Venous blood samples | 8 weeks |
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