search
Back to results

A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay (EMBOL1)

Primary Purpose

Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Venepuncture
Fingerstick
Sponsored by
LumiraDx UK Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitäres Herz- und Gefäßzentrum Hamburg
  • Addenbrookes Hospital
  • Royal Infirmary of Edinburgh
  • Epsom and St Helier Hospitals
  • Glsagow Royal Infirmary
  • Queen Elizabeth University Hospital
  • St Johns Hospital
  • Homerton University Hospital NHS Foundation Trust
  • Royal London Hospital
  • St Georges Hospital
  • University College Hospital
  • Manchester Royal Infirmary
  • South Warwickshire Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspected VTE patients

Arm Description

Venous blood draw of up to 20ML and up to 6 fingerstick capillary draws

Outcomes

Primary Outcome Measures

Determine the accuracy of the LumiraDx POC D-Dimer assay when compared to a reference method in patients with suspected VTE.
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).
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

Secondary Outcome Measures

Full Information

First Posted
February 1, 2021
Last Updated
September 20, 2022
Sponsor
LumiraDx UK Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT04737954
Brief Title
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Acronym
EMBOL1
Official Title
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LumiraDx UK Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
IVD Performance Evaluation Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Suspected VTE patients
Arm Type
Experimental
Arm Description
Venous blood draw of up to 20ML and up to 6 fingerstick capillary draws
Intervention Type
Diagnostic Test
Intervention Name(s)
Venepuncture
Intervention Description
Venous blood draw
Intervention Type
Diagnostic Test
Intervention Name(s)
Fingerstick
Intervention Description
Capillary blood draw
Primary Outcome Measure Information:
Title
Determine the accuracy of the LumiraDx POC D-Dimer assay when compared to a reference method in patients with suspected VTE.
Description
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.
Time Frame
2 months
Title
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).
Description
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
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Body
Organizational Affiliation
Professor of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäres Herz- und Gefäßzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom
Facility Name
Epsom and St Helier Hospitals
City
Epsom
Country
United Kingdom
Facility Name
Glsagow Royal Infirmary
City
Glasgow
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Facility Name
St Johns Hospital
City
Livingston
Country
United Kingdom
Facility Name
Homerton University Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
Country
United Kingdom
Facility Name
St Georges Hospital
City
London
Country
United Kingdom
Facility Name
University College Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
South Warwickshire Foundation Trust
City
Warwick
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay

We'll reach out to this number within 24 hrs