EMBOL1: A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Study Details
Study Description
Brief Summary
In patients with symptoms of Venous Thromboembolism (VTE) (mainly deep vein thrombosis (DVT) or pulmonary embolism (PE)), the study will evaluate the agreement between the D-Dimer measurements from the LumiraDx POC D-Dimer assay and a reference method, as an aid in diagnosis, assessment and exclusion of DVT and PE.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a performance evaluation study designed to assess the precision and accuracy of the LumiraDx Point of Care (POC) D-Dimer test when used in patients presenting with symptoms of Venous thromboembolism (VTE), which mainly comprises deep vein thrombosis (DVT) or pulmonary embolism (PE).
The LumiraDx POC D-Dimer test is a quantitative immunoassay providing results in under 10 minutes. The accuracy of the LumiraDx POC D-Dimer test will be assessed using capillary whole blood, venous blood, and plasma samples, by comparison to the D-Dimer results obtained from the same individuals as analysed by trained laboratory professionals using a reference device. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test in the European Union (EU) and other relevant geographies.
Adult males and females presenting to the study sites with symptoms of VTE will be included in the study. Approximately 1000 subjects will be recruited in total. An initial analysis will be completed on the first 200 patients to determine accuracy of the LumiraDx D-Dimer test versus the reference method. The study will continue until 1000 patients are recruited and with a minimum of 120 confirmed VTE events, in order to complete retrospective analysis using the LumiraDx D-Dimer cut-off for exclusion of VTE.
Once consent is obtained, blood tube samples will be drawn and finger-stick samples of capillary blood will be taken from the subject, these will be applied directly to unique test strips for immediate measurement of D-Dimer on the LumiraDx POC D-Dimer test.
The D-Dimer results obtained via the LumiraDx D-Dimer test will be used in a set of comparative analyses designed to determine the performance characteristics of the test. This study is an observational, cross-sectional design. As an observational study of an investigative device, results obtained during the course of the study will not inform or alter patient management or treatment decisions in any way.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Suspected VTE patients Venous blood draw of up to 20ML and up to 6 fingerstick capillary draws |
Diagnostic Test: Venepuncture
Venous blood draw
Diagnostic Test: Fingerstick
Capillary blood draw
|
Outcome Measures
Primary Outcome Measures
- Determine the accuracy of the LumiraDx POC D-Dimer assay when compared to a reference method in patients with suspected VTE. [2 months]
Measurement of blood samples from patients with suspected VTE in a reference method and in the LumiraDx method to assess accuracy of the LumiraDx method.
- Assessment of accuracy of using the D-Dimer cut-off set by the LumiraDx D-Dimer test in excluding patients with symptoms of VTE (DVT and PE) when used in combination with the pre-probability test (Wells Score). [10 months]
Measurement of blood samples from patients with suspected VTE in the LumiraDx D-dimer assay in conjunction with pre-test probability score and final clinical outcome in order to set a clinical cut-off for the LumiraDx D-dimer assay
Eligibility Criteria
Criteria
Inclusion Criteria:
Subject is greater or equal to 18 years of age Willing and able to provide written informed consent and comply with study procedures Symptoms of thromboembolic event
Exclusion Criteria:
Suspected Sinus Venous Thromboembolism / Cerebral Venous Sinus Thromboembolism End-stage renal failure on haemodialysis Current anticoagulant therapy (Fragmin, LMWH) within the last 30 days Patient has previously participated in this study Life expectancy documented as <30 days Haemodynamically unstable (e.g. cardiogenic shock) Patients taking anticoagulant therapy (DOACS, Warfarin, Heparins etc) within the last 30 days Patient deemed medically unfit to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitäres Herz- und Gefäßzentrum Hamburg | Hamburg | Germany | 20246 | |
| 2 | Addenbrookes Hospital | Cambridge | United Kingdom | ||
| 3 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | ||
| 4 | Epsom and St Helier Hospitals | Epsom | United Kingdom | ||
| 5 | Glsagow Royal Infirmary | Glasgow | United Kingdom | ||
| 6 | Queen Elizabeth University Hospital | Glasgow | United Kingdom | ||
| 7 | St Johns Hospital | Livingston | United Kingdom | ||
| 8 | Homerton University Hospital NHS Foundation Trust | London | United Kingdom | ||
| 9 | Royal London Hospital | London | United Kingdom | ||
| 10 | St Georges Hospital | London | United Kingdom | ||
| 11 | University College Hospital | London | United Kingdom | ||
| 12 | Manchester Royal Infirmary | Manchester | United Kingdom | ||
| 13 | Salford Care Organisation | Manchester | United Kingdom | ||
| 14 | South Warwickshire Foundation Trust | Warwick | United Kingdom |
Sponsors and Collaborators
- LumiraDx UK Limited
Investigators
- Principal Investigator: Richard Body, Professor of Emergency Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S-CLIN-PROT-00006