Aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis in orthopaedic trauma patients: A patient-centered randomized controlled trial.

研究概要

Three hundred and twenty-nine patients with a traumatic extremity fracture requiring operative treatment where venous thromboembolism prophylaxis was needed were randomized to receive either low-molecular weight heparin (LMWH) or aspirin. The primary outcome of interest included the incidence of mortality, bleeding, venous thromboembolism (VTE), deep surgical site infection, and a combination of these adverse outcomes. Outcomes were assessed up to 90 days of sustaining the injury. Furthermore, treatment superiority was calculated using the Global Rank test and time to event analysis. The incidence of adverse events were similar between the two treatment arms, including the proportion of event-free patients, 90 days post-operation (59.9% vs. 59.4%). With regards to the Global Rank test, LMWH was 50.4% (95%CI [47.7, 53.2], p=0.73) superior to aspirin, however this did not meet the 59% benefit threshold. In the time to event analysis, the LMWH group demonstrated a 60.5% (95%CI [24.3, 88.0], p=0.59) probability, however considerable uncertainty was associated with this result.