A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay (EMBOL1)
Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
About this trial
This is an interventional diagnostic trial for Deep Vein Thrombosis
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
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
Experimental
Suspected VTE patients
Venous blood draw of up to 20ML and up to 6 fingerstick capillary draws