Details
The U.S. Food and Drug Administration (FDA) pursued this study in TriNetX Live™, an aggregated electronic health record (EHR)-based data source, part of the Sentinel System, to learn more about the natural history of coagulopathy in patients with COVID-19. The study aimed to describe individuals hospitalized with COVID-19 who had arterial or venous cardiovascular events (i.e., pulmonary embolism, deep venous thrombosis, stroke, and myocardial infarction) and who were treated with anticoagulants. The study also served to evaluate the feasibility of using real-world EHR data from TriNetX to inform questions related to coagulopathy in COVID-19 patients.
Among ~12,560 hospitalized COVID-19 patients (through June 2020), thrombotic conditions, other COVID-19 severity related conditions, selected medications (days 0-14), and selected laboratory tests (days 0-7) were assessed following their COVID-19 diagnosis or associated hospitalization admission (day 0). Overall, 2.5% of patients had a diagnosis of pulmonary embolism, 2.1% of deep vein thrombosis, 2.4% of ischemic stroke, and 3.9% had a myocardial infarction diagnosis. The most frequent COVID-19 severity related outcome was pneumonia (52.0%). Select medications used in these patients included heparin (20.1%) and low molecular weight heparin (36.1%). Key laboratory data were available for a subset of patients (hemoglobin: 90.8%, d-dimer (FEU): 25.5%, d-dimer (DDU): 17.9%).
The results of this study contributed to the Reagan-Udall Foundation/Friends of Cancer Research Evidence Accelerator discussions with the scientific community, to explore how real-world data (RWD) can quickly address questions on COVID-19 therapeutics. These results also informed an epidemiologic study on the natural history of coagulopathy conducted using data from six Sentinel Data Partners.