NOACs Versus LMWH in Critically Ill Patients with COVID-19
Description
Research Hypothesis: This study hypothesizes that the use of Novel Oral Anticoagulants (NOACs) compared to Low-Molecular-Weight Heparin (LMWH) in critically ill COVID-19 patients before the vaccination era results in different clinical outcomes, particularly in terms of thrombotic and bleeding events. Objective: To compare the effectiveness and safety of NOACs with those of low-molecular-weight heparins (LMWHs) among unvaccinated critically ill patients. Data Overview: The dataset was extracted from the Epimed Monitor system, encompassing a retrospective, observational, unicentric study of critically ill patients with COVID-19. The data includes detailed clinical and demographic information, as well as treatment outcomes for patients who received either NOACs or LMWH. This dataset was carefully filtered and organized in RStudio to support robust statistical analyses. Notable Findings: Preliminary analyses indicate potential differences in outcomes between patients treated with NOACs versus LMWH, particularly concerning the incidence of thrombotic events and major bleeding. These findings suggest the need for further investigation into the efficacy and safety of these anticoagulants in critically ill patients during the pre-vaccination period of the COVID-19 pandemic. Data Interpretation: The dataset includes deidentified participant data, structured into multiple variables that capture relevant clinical information, treatment regimens, and patient outcomes. Users of this data can replicate the analyses conducted in this study or perform secondary analyses to explore additional hypotheses. The dataset is particularly valuable for researchers interested in the management of anticoagulation in critically ill COVID-19 patients. Usage and Accessibility: The data is publicly accessible via Mendeley Data and can be used by other researchers following appropriate citation. This dataset is a valuable resource for understanding the impact of different anticoagulant therapies on the clinical outcomes of COVID-19 patients in intensive care settings before the availability of vaccines.
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Steps to reproduce
Steps to Reproduce: This dataset was derived from a retrospective, single-center cohort study conducted at a tertiary medical center in Rio de Janeiro, Brazil. The data collection process involved two main steps: Data Filtration: First Tier: Electronic health records (EHRs) were used to identify 88 initial patients treated with either NOACs (33 apixaban and 2 rivaroxaban recipients) or LMWH (41 enoxaparin recipients) for anticoagulation or thromboprophylaxis in the ICU. Second Tier: A manual review refined this to a final cohort of 76 patients, ensuring all participants were aged ≥ 18 years, had consistent anticoagulation throughout their ICU stay, and had confirmed SARS-CoV-2 testing. Patients with prior anticoagulation use or without definitive SARS-CoV-2 testing were excluded. Data Collection and Management: Data were extracted from the Epimed Monitor ICU Database®, a Brazilian clinical data management system designed specifically for ICUs. This system provided a robust platform for collecting, analyzing, and benchmarking clinical and operational data related to ICU patients. The study included patients admitted with severe COVID-19 between March 23, 2020, and December 14, 2020. All patient data were anonymized and de-identified to ensure confidentiality. Ethical Considerations: The study was approved by the Ethics Committee of Pró-Cardíaco Hospital, Rio de Janeiro (CAAE: 68235323.3.0000.5533), in October 2021. Due to the retrospective nature of the study, informed consent was waived. The study adhered to the Declaration of Helsinki. Methodology and Analysis: A post-hoc power analysis was conducted to confirm the study’s capacity to detect significant differences between the treatment groups. Data analysis was performed using RStudio.