Status:
UNKNOWN
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Lead Sponsor:
LumiraDx UK Limited
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 thromboem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04737954
Start Date
March 18 2021
End Date
September 1 2022
Last Update
September 21 2022
Active Locations (13)
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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