Abstract
BACKGROUND: Critically ill patients are at high risk for venous thromboembolism (VTE). In non-Caucasian patients, routine thromboprophylaxis is controversial. No standard guidelines exist for critically ill Thai patients. OBJECTIVES: To evaluate the efficacy and safety of a risk-adapted VTE prophylaxis protocol in medically ill patients. METHODS: A single-center, prospective pre- and post-implementation trial conducted from March to December 2024. Patients admitted to three medical ICUs were enrolled. Patients were stratified by risk of VTE and bleeding. In the pre-implementation phase, patients did not receive thromboprophylaxis, whereas in the post-implementation phase, patients received thromboprophylaxis with either pharmacological or mechanical prophylaxis. The primary outcome was the 45-day incidence of VTE, VTE-related death, and bleeding events. Secondary outcomes included all-cause mortality, ICU stay, and days on mechanical ventilation. RESULTS: There were 462 patients enrolled with a mean age of 65.82 ± 16.65 years and 53.90% were male. In the post-implementation phase, 151 out of 211 patients (65.37%) received thromboprophylaxis, primarily with pneumatic compression (41.56%), low molecular weight heparin/unfractionated heparin (15.58%) and aspirin (7.36%). VTE events occurred in 14 patients (6.06%) in the pre-implementation group and 5 (2.16%) in the post-implementation group. The composite primary outcome occurred in 14 patients (6.06%, 95% CI 3.35-9.96%) in the pre-implementation group and 5 (2.16%, 95% CI 0.71-4.98%) in the post-implementation group (RR 0.35, 95% CI 0.13-0.97, P = 0.04). A competing-risks analysis showed that post-implementation group was associated with significantly lower risk of VTE (adjusted subdistribution hazard ratio 0.35, 95% CI 0.13-0.97; p = 0.043). No VTE-related deaths occurred. Overall bleeding occurred in 28.14% of pre-implementation and 32.03% of post-implementation patients (RR 1.13, 95% CI 0.86-1.50, P = 0.361). Major bleeding rates were 11.26% vs. 8.22%, respectively (RR 0.65, 95% CI 0.40-1.07, P = 0.075). CONCLUSION: A risk-adapted VTE prophylaxis protocol significantly reduced VTE incidence in critically ill Asian patients without increasing bleeding complication. CLINICAL TRIAL REGISTRATION: TCTR20230927002, First Posted Date: 27 September 2023.