venous thrombosis pulmonary embolism
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients are eligible for the study if: - The general practitioner (GP) has a suspicion of deep venous thrombosis (DVT) or pulmonary embolism (PE), i.e. unexplained pain, swelling, and/or redness of the leg in case of DVT, or unexplained shortness of breath and pain when breathing in case of PE. - Patients have a low score on a clinical decision rule (low pre-test probability of DVT or PE), and thus the GP aims to rule-out VTE (if possible) using routine care D-dimer testing.
Exclusion criteria
Exclusion criteria: Exclusion criteria are: - Age below 18. - Already using anticoagulant treatment with vitamin K antagonists, Non vitamin K Oral Anti Coagulants (NOAC) and/or low molecular-weight heparin (LMWH). - With a non-low score on a clinical decision rule - With an already determined POC D-dimer by the GP, suitable for risk stratification - Life expectancy less than 3 months. - Unwilling to participate with this study (opt-out procedure).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For our primary objective, we will quantify the diagnostic power to (safely) rule out VTE by calculating the failure rate, plus corresponding 95% CI (using Fischer*s exact test) of each POC D-dimer assay, both for using a fixed cut-of value of 500 ng/ml and for using an age-dependent cut-off. The failure rate is defined as the proportion of patients diagnosed with VTE during 3 months of follow-up in those with D-dimer below the chosen threshold in our study patients (i.e. those with a low score on the CDR). | — |
Secondary
| Measure | Time frame |
|---|---|
| The added diagnostic information from inflammatory or coagulation biomarkers will be quantified by using multivariable logistic regression analysis, with VTE presence as the binary outcome of the model. Various logistic models will be constructed. In a first basic model, (inflammatory - CRP, procalcitonin and/or coagulation - TAT) biomarkers will be added to a model including all items from the CDR plus the results from D-dimer testing. Next, this model will be expanded using interaction terms for biomarker results with D-dimer testing, CDR score, gender and/or age. Biomarker results will be added as continuous variables, after checking linearity assumptions. In a limited number of study patients (100 of 750 EVA patients) a POC measurement is done in the GP's office with blood of a vingerprick additional to the venapuncture in the laboratory. | — |
Countries
Netherlands
Outcome results
None listed