Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)
OPTIMAL
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
1 other identifier
interventional
420
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2018
CompletedFirst Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2018
CompletedFebruary 27, 2019
September 1, 2018
2 months
September 19, 2018
February 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the clinical performance of the LumiraDx instrument
Measurement of INR using Capillary \& Venous blood samples
8 weeks
Secondary Outcomes (1)
To determine the accuracy of the LumiraDx instrument
8 weeks
Study Arms (2)
VKA Patients
EXPERIMENTALSingle Arm - blood collection by venepuncture and fingerstick in patients undergoing Warfarin Therapy
non-Vka Patients
EXPERIMENTALSingle Arm - blood collection by venepuncture and fingerstick in patients not undergoing Warfarin Therapy
Interventions
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Glasgow Royal Infirmary Clinical Research Facility
Glasgow, G4 0SF, United Kingdom
Golden Jubilee National Hospital
Glasgow, G81 4DY, United Kingdom
Wishaw General Hospital, NHS Lanarkshire
Wishaw, ML2 0DP, United Kingdom
Related Publications (1)
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.
PMID: 31773973DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert C Tait, BSc (Hons)
Consultant Haematologist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 24, 2018
Study Start
September 17, 2018
Primary Completion
November 23, 2018
Study Completion
November 23, 2018
Last Updated
February 27, 2019
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share