Evaluating a New Clinical Decision Support Tool Using Fresh and Frozen Plasma to Diagnose Venous Thromboembolism in Patients with Suspected PE or DVT

What this Trial Is About

This research evaluates the diagnostic performance of a new Clinical Decision Support tool using fresh plasma samples in patients suspected of venous thromboembolism VTE, including pulmonary embolism PE and deep vein thrombosis DVT. It compares results from fresh plasma with those from frozen plasma and the current standard diagnostic strategy. The study includes various patient groups, such as those eligible for D-dimer testing, patients with high clinical probability, patients with conditions affecting D-dimer levels, those with recent thrombotic events, active cancer, or COVID-19. The study uses routine coagulation tests and the new Clinical Decision Support algorithm on both fresh and frozen plasma samples. The algorithm applies manual or machine learning methods to calculate exclusion scores based on D-dimer and fibrin formation assays. Participants receive standard care and diagnosis according to usual practice while their plasma samples are assessed for comparison. Participants will undergo plasma sampling for routine coagulation and Clinical Decision Support testing on fresh and frozen samples. Researchers will measure outcomes including reproducibility, threshold settings, sensitivity, specificity, likelihood ratios, exclusion percentages, and negative predictive values of the Clinical Decision Support tool over periods of 37 to 48 months. The study aims to verify if fresh plasma testing can match frozen plasma performance, potentially impacting diagnostic algorithms for VTE.

Exclusion of Venous Thrombo-Embolism With a New Clinical Decision Support