Clinical trial NCT04737954: A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Official title: A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Venous Thromboembolism
Lead sponsor: LumiraDx UK Limited
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: IVD Performance Evaluation Study
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Determine the accuracy of the LumiraDx POC D-Dimer assay when compared to a reference method in patients with suspected VTE.
timeFrame: 2 months
measure: 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).
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum Hamburg
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Epsom
country: United Kingdom
facility: Epsom and St Helier Hospitals
city: Glasgow
country: United Kingdom
facility: Glsagow Royal Infirmary
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Livingston
country: United Kingdom
facility: St Johns Hospital
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: University College Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Warwick
country: United Kingdom
facility: South Warwickshire Foundation Trust
Study officials:
affiliation: Professor of Emergency Medicine
name: Richard Body
role: PRINCIPAL_INVESTIGATOR
References: