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Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)

Sponsor
LumiraDx UK Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03682419
Collaborator
(none)
420
Enrollment
3
Locations
2
Arms
2.2
Actual Duration (Months)
140
Patients Per Site
63.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: VKA Patients
  • Procedure: Non-VKA Patients
 N/A

Detailed Description

A performance evaluation study designed to assess the precision and accuracy of the LumiraDx Instrument, a point of care in vitro diagnostic system employing a portable diagnostic meter in conjunction with single use analyte test strips, for the quantitative determination of Prothrombin Time expressed as International Normalised Ratio (INR), as sampled from individuals evaluated for INR at the point of care (POC).

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
420 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
A performance evaluation study.A performance evaluation study.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official 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
Actual Study Start Date :
Sep 17, 2018
Actual Primary Completion Date :
Nov 23, 2018
Actual Study Completion Date :
Nov 23, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: VKA Patients

Single Arm - blood collection by venepuncture and fingerstick in patients undergoing Warfarin Therapy

Procedure: VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients

    • Procedure: Non-VKA Patients
    Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
    Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients

    		•
    Experimental: non-Vka Patients

    Single Arm - blood collection by venepuncture and fingerstick in patients not undergoing Warfarin Therapy

    Procedure: VKA Patients
    Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
    Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients

    • Procedure: Non-VKA Patients
    Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
    Other Names:
  • Fingerstick to collect blood samples from Patients
  • Venepuncture to collect blood samples from Patients

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine the clinical performance of the LumiraDx instrument [8 weeks]

      Measurement of INR using Capillary & Venous blood samples

    Secondary Outcome Measures

    1. To determine the accuracy of the LumiraDx instrument [8 weeks]

      Measurement of INR & Haematocrit using Capillary & Venous blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glasgow Royal Infirmary Clinical Research Facility Glasgow United Kingdom G4 0SF
    2 Golden Jubilee National Hospital Glasgow United Kingdom G81 4DY
    3 Wishaw General Hospital, NHS Lanarkshire Wishaw United Kingdom ML2 0DP

    Sponsors and Collaborators

    • LumiraDx UK Limited

    Investigators

    • Principal Investigator: Robert C Tait, BSc (Hons), Consultant Haematologist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LumiraDx UK Limited
    ClinicalTrials.gov Identifier:
    NCT03682419
    Other Study ID Numbers:
    • D-CLIN-PROT-00001
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    Feb 27, 2019
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Atrial Fibrillation
    Myocardial Infarction
    Thrombosis
    Embolism
    Venous Thrombosis
    Thrombophilia
    Antiphospholipid Syndrome
    Syndrome

    Study Results

    No Results Posted as of Feb 27, 2019