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

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ClinicalTrials.gov Identifier: NCT03682419
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
LumiraDx UK Limited

Study Description
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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
Deep Vein Thrombosis Atrial Fibrillation Post-Myocardial Infarction Syndrome Pulmonary Embolism Artificial Heart Device User Thrombophilia Antiphospholipid Syndrome Procedure: VKA Patients Procedure: Non-VKA Patients Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : September 17, 2018
Estimated Primary Completion Date : November 12, 2018
Estimated Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. To determine the clinical performance of the LumiraDx instrument [ Time Frame: 8 weeks ]
    Measurement of INR using Capillary & Venous blood samples


Secondary Outcome Measures :
  1. To determine the accuracy of the LumiraDx instrument [ Time Frame: 8 weeks ]
    Measurement of INR & Haematocrit using Capillary & Venous blood samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682419


Contacts
Contact: Karen Lang, PhD 07867 808302 karen.lang@lumiradx.com
Contact: Sandy Fell 07713 053273 sandy.fell@lumiradx.com

Locations
United Kingdom
Glasgow Royal Infirmary Clinical Research Facility Not yet recruiting
Glasgow, United Kingdom, G4 0SF
Contact: Janet Johnstone    0141 211 4681    Janet.Johnstone@ggc.scot.nhs.uk   
Principal Investigator: Robert C Tait, BSc, MBChB, FRCP, FRCPath         
Golden Jubilee National Hospital Not yet recruiting
Glasgow, United Kingdom, G81 4DY
Contact: Sinéad McKee    0141 951 5535    sinead.mckee@nhs.net   
Principal Investigator: Roy S Gardner, MBChB, MD, MRCP, FESC, FHFA         
Wishaw General Hospital, NHS Lanarkshire Recruiting
Wishaw, United Kingdom, ML2 0DP
Contact: Maxine Fernon    01236 713432    Maxine.Fernon@lanarkshire.scot.nhs.uk   
Principal Investigator: Annielle Hung, MCchB         
Sponsors and Collaborators
LumiraDx UK Limited
Investigators
Principal Investigator: Robert C Tait, BSc (Hons) Consultant Haematologist
More Information
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Responsible Party: LumiraDx UK Limited
ClinicalTrials.gov Identifier: NCT03682419     History of Changes
Other Study ID Numbers: D-CLIN-PROT-00001
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Syndrome
Atrial Fibrillation
Infarction
Myocardial Infarction
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Antiphospholipid Syndrome
Thrombophilia
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Hematologic Diseases
Warfarin
Anticoagulants