NCT04737954

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
2 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 18, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

February 1, 2021

Last Update Submit

September 20, 2022

Conditions

Deep Vein ThrombosisPulmonary EmbolismVenous Thromboembolism

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 months

  • 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

    10 months

Study Arms (1)

Suspected VTE patients

EXPERIMENTAL

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

Diagnostic Test: VenepunctureDiagnostic Test: Fingerstick

Interventions

VenepunctureDIAGNOSTIC_TEST

Venous blood draw

Suspected VTE patients
FingerstickDIAGNOSTIC_TEST

Capillary blood draw

Suspected VTE patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, 20246, Germany

Location

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Epsom and St Helier Hospitals

Epsom, United Kingdom

Location

Glsagow Royal Infirmary

Glasgow, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

St Johns Hospital

Livingston, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

St Georges Hospital

London, United Kingdom

Location

University College Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

South Warwickshire Foundation Trust

Warwick, United Kingdom

Location

MeSH Terms

Conditions

Venous ThrombosisPulmonary EmbolismVenous Thromboembolism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolismThromboembolism

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Richard Body

    Professor of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: IVD Performance Evaluation Study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

March 18, 2021

Primary Completion

June 30, 2022

Study Completion

September 1, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)GB(12)