Venous thromboembolism prophylaxis with anticoagulation in septic patients: a prospective cohort study

Background: Venous thromboembolism (VTE) is a feared complication during hospitalization. The practice of administering pharmacological prophylaxis is highly endorsed despite failure of studies to show reduction in mortality. Aim: To determine the benefit of VTE prophylaxis in acutely ill medical patients with sepsis. Methods: A prospective cohort, with enrollment between January 2010 and April 2011. Patients were detected in four medicine departments at a university-affiliated hospital and followed for 90 days for pre-specified outcomes. We included all septic patients at high VTE risk defined by Padua score >= 4. The primary outcome was 30-day mortality. Incidence of pulmonary embolism, deep vein thrombosis or major bleeding episodes at 30 and 90 days, and 90-day mortality were secondary outcomes. Results: A total of 1540 patients were identified, of which 720 (55%) were at high risk for VTE and included. A total of 213 (29.6%) patients received prophylaxis. VTE occurred in 6 control patients and 2 treated (0.9 and 1.2%, respectively, RR 0.79, CI: 0.16-3.95). Major bleeding events occurred in 4 (0.8%) control and 7 (3.3%) treated patients (RR 4.1, CI: 1.24-14.08, P = 0.01). After adjusting for covariates, VTE prophylaxis conferred no 30- or 90-day mortality benefit (OR 1.24, CI: 0.79-1.93 and OR 1.47, CI: 0.99-2.17, respectively). Lack of significant benefit with prophylaxis persisted after propensity-score matching (OR for 30-day mortality 1.01, CI: 0.66-1.55). Conclusions: In acutely ill inpatients with sepsis, no significant benefit was demonstrated for VTE prophylaxis, with higher rates of bleeding. The risk-benefit ratio of this intervention should be carefully examined.