6/30/23, 2:23 AM The da Vinci Trial Pathway Feedback Search Clinical Topics Home Studies The da Vinci Trial The da Vinci Trial Trial question What is the role of early prophylactic placement of vena cava filter in patients with major trauma? Study design Multi-center Open label RCT Population Characteristics of study participants 23.0% female N = 240 77.0% male 240 patients (56 female, 184 male) Inclusion criteria: severely injured patients who had a contraindication to anticoagulant agents Key exclusion criteria: imminent death, confirmed PE on admission to the trial center, systemic anticoagulant treatment before injury, pregnancy, and unavailability of an interventional radiologist to insert the filter within 72 hours after admission Interventions N=122 vena cava filter (filter placed within the first 72 hours after admission for the injury) N=118 control (no filter placement) Primary outcome Symptomatic pulmonary embolism or death from any cause at 90 days 14.4 % 14.4 13.9 10.8 % 7.2 % 3.6 % No significant difference 0.0 % https://web.pathway.md/studies/recN8ebhFqmOSZlL3 1/2 6/30/23, 2:23 AM 0 0 % The da Vinci Trial Pathway Vena cava filter Control No significant difference in symptomatic PE or death from any cause at 90 days (13.9% vs. 14.4%; HR 0.99, 99% CI 0.51 to 1.94) Secondary outcomes No significant difference in death from any cause at 90 days (13.1% vs. 9.3%; RR 1.41, 95% CI 0.69 to 2.87) No significant difference in major bleeding at 90 days (70.5% vs. 66.1%; RR 1.07, 95% CI 0.9 to 1.27) Safety outcomes No significant difference in incidence of major and nonmajor bleeding and deep vein thrombosis in a leg. Significant difference in entrapped thrombus within the filter noted at the first attempt to remove the filter (4.9% vs. n/a). Conclusion In severely injured patients who had a contraindication to anticoagulant agents, vena cava filter was not superior to control with respect to symptomatic PE or death from any cause at 90 days. Reference Kwok M Ho, Sudhakar Rao, Stephen Honeybul et al. A Multicenter Trial of Vena Cava Filters in Severely Injured Patients. N Engl J Med. 2019 Jul 25;381(4):328-337. Open reference URL https://web.pathway.md/studies/recN8ebhFqmOSZlL3 2/2