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Completed
NCT04737954
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Conditions: Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 679
Sponsor: LumiraDx UK Limited
Location: Universitäres Herz- und Gefäßzentrum Hamburg Hamburg
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.
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 \
Source: ClinicalTrials.gov (NCT04737954). StuddyBuddy aggregates publicly available trial information.
