Heart failure
Conditions
Interventions
None listed
Sponsors
Siemens Healthineers Nederland B.V./Point of Care Business
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age>/= 22 year; and Patients with suspected or diagnosed heart failure, deep vein thrombosis and/or pulmonary embolism; and Competent patients who have given consent and signed for participation.
Exclusion criteria
Exclusion criteria: Age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome consists of the regression parameters (including slope and associated 95% confidence interval) of a regression analysis of the measurement results of the Atellica VTLi System. The regression used for this will be the Passing-Bablok method or other regression method recommended by CLSI EP09c. The regression parameters will be calculated for the combinations of sample types, as follows: • Venous whole blood / capillary • Venous whole blood / venous plasma • Capillary / Venous Plasma This analysis will be performed for all three analytes (BNP, NT-proBNP and D-dimer), thus resulting in 9 regressions. The correlation coefficient will also be determined for each of the 9 data sets. In addition, the bias in Bland-Altman plots of samples above the limit of quantification (LoQ) will be determined for the different pairs of samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is a graph and bias determination of the differences between venous whole blood and plasma measurements, using a Bland-Altman analysis. Hematocrit (x-axis) will be plotted against the percent difference between whole blood and plasma results (y-axis). Analysis by regression will determine the possible bias and maximum hematocrit value. Analysis of data from the method comparison study will consist of the above regression parameters based on Passing-Bablok analysis and an associated correlation coefficient for each analyte, comparing the measurement results on reference equipment (x-axis) with the measurement results on the Atellica VTLi System (y-axis). | — |
Countries
Netherlands
Outcome results
None listed