Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL) (OPTIMAL)
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| ClinicalTrials.gov Identifier: NCT03682419 |
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Recruitment Status :
Recruiting
First Posted : September 24, 2018
Last Update Posted : September 24, 2018
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| 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 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VKA Patients
Single Arm - blood collection by venepuncture and fingerstick in patients undergoing Warfarin Therapy
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Procedure: VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Other Names:
Procedure: Non-VKA Patients Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Other Names:
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Experimental: non-Vka Patients
Single Arm - blood collection by venepuncture and fingerstick in patients not undergoing Warfarin Therapy
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Procedure: VKA Patients
Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
Other Names:
Procedure: Non-VKA Patients Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
Other Names:
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- To determine the clinical performance of the LumiraDx instrument [ Time Frame: 8 weeks ]Measurement of INR using Capillary & Venous blood samples
- To determine the accuracy of the LumiraDx instrument [ Time Frame: 8 weeks ]Measurement of INR & Haematocrit using Capillary & Venous blood samples
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
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
| Contact: Karen Lang, PhD | 07867 808302 | karen.lang@lumiradx.com | |
| Contact: Sandy Fell | 07713 053273 | sandy.fell@lumiradx.com |
| 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 | |
| Principal Investigator: | Robert C Tait, BSc (Hons) | Consultant Haematologist |
| 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:
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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 |