Kwok M Ho1, Sudhakar Rao1, Stephen Honeybul1, Rene Zellweger1, Bradley Wibrow1, Jeffrey Lipman1, Anthony Holley1, Alan Kop1, Elizabeth Geelhoed1, Tomas Corcoran1, Philip Misur1, Cyrus Edibam1, Ross I Baker1, Jenny Chamberlain1, Claire Forsdyke1, Frederick B Rogers1. 1. From the Departments of Intensive Care Medicine (K.M.H., J.C.), Neurosurgery (S.H.), and Radiology (P.M.), the State Trauma Unit (S.R., R.Z., C.F.), and the Centre for Implant Technology and Retrieval Analysis, Department of Medical Engineering and Physics (A.K.), Royal Perth Hospital, the Schools of Population and Global Health (K.M.H.), Allied Health (E.G.), and Medicine and Pharmacology (B.W., T.C.), University of Western Australia, and the School of Veterinary and Life Sciences (K.M.H.) and the Western Australian Centre for Thrombosis and Haemostasis (R.I.B.), Murdoch University, Perth, WA, the Departments of Neurosurgery (S.H.) and Intensive Care Medicine (B.W.), Sir Charles Gairdner Hospital, Nedlands, WA, Critical Care Services, Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (J.L., A.H.), and the Department of Intensive Care Medicine, Fiona Stanley Hospital, Murdoch, WA (C.E.) - all in Australia; and Trauma Services, Lancaster General Hospital, University of Pennsylvania, Lancaster (F.B.R.).
Abstract
BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in thevena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).
RCT Entities:
BACKGROUND: Whether early placement of an inferior vena cava filter reduces the risk of pulmonary embolism or death in severely injured patients who have a contraindication to prophylactic anticoagulation is not known. METHODS: In this multicenter, randomized, controlled trial, we assigned 240 severely injured patients (Injury Severity Score >15 [scores range from 0 to 75, with higher scores indicating more severe injury]) who had a contraindication to anticoagulant agents to have a vena cava filter placed within the first 72 hours after admission for the injury or to have no filter placed. The primary end point was a composite of symptomatic pulmonary embolism or death from any cause at 90 days after enrollment; a secondary end point was symptomatic pulmonary embolism between day 8 and day 90 in the subgroup of patients who survived at least 7 days and did not receive prophylactic anticoagulation within 7 days after injury. All patients underwent ultrasonography of the legs at 2 weeks; patients also underwent mandatory computed tomographic pulmonary angiography when prespecified criteria were met. RESULTS: The median age of the patients was 39 years, and the median Injury Severity Score was 27. Early placement of a vena cava filter did not result in a significantly lower incidence of symptomatic pulmonary embolism or death than no placement of a filter (13.9% in the vena cava filter group and 14.4% in the control group; hazard ratio, 0.99; 95% confidence interval [CI], 0.51 to 1.94; P = 0.98). Among the 46 patients in the vena cava filter group and the 34 patients in the control group who did not receive prophylactic anticoagulation within 7 days after injury, pulmonary embolism developed in none of those in the vena cava filter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). An entrapped thrombus was found in the filter in 6 patients. CONCLUSIONS: Early prophylactic placement of a vena cava filter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90 days than no placement of a filter. (Funded by the Medical Research Foundation of Royal Perth Hospital and others; Australian New Zealand Clinical Trials Registry number, ACTRN12614000963628.).
Authors: Jori E May; Patrick C Irelan; Kailee Boedeker; Emily Cahill; Steven Fein; David A Garcia; Lisa K Hicks; Janice Lawson; Ming Y Lim; Colleen T Morton; Anita Rajasekhar; Satish Shanbhag; Marc S Zumberg; Robert M Plovnick; Nathan T Connell Journal: Blood Adv Date: 2020-09-22
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Authors: David R Anderson; Gian Paolo Morgano; Carole Bennett; Francesco Dentali; Charles W Francis; David A Garcia; Susan R Kahn; Maryam Rahman; Anita Rajasekhar; Frederick B Rogers; Maureen A Smythe; Kari A O Tikkinen; Adolph J Yates; Tejan Baldeh; Sara Balduzzi; Jan L Brożek; Itziar Etxeandia- Ikobaltzeta; Herman Johal; Ignacio Neumann; Wojtek Wiercioch; Juan José Yepes-Nuñez; Holger J Schünemann; Philipp Dahm Journal: Blood Adv Date: 2019-12-10