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

NCT03682419 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2019-02-27

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

VKA Patients

Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy

PROCEDURE

Non-VKA Patients

Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy

Sponsors & Collaborators

  • LumiraDx UK Limited

    lead INDUSTRY

Principal Investigators

  • Robert C Tait, BSc (Hons) · Consultant Haematologist

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2018-11-23
Completion
2018-11-23

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03682419 on ClinicalTrials.gov