• Major Extremity Trauma Research Consortium (METRC), Robert V O'Toole, Deborah M Stein, Nathan N O'Hara, Katherine P Frey, Tara J Taylor, Daniel O Scharfstein, Anthony R Carlini, Kuladeep Sudini, Yasmin Degani, Gerard P Slobogean, Elliott R Haut, William Obremskey, Reza Firoozabadi, Michael J Bosse, Samuel Z Goldhaber, Debra Marvel, and Renan C Castillo.
• From the Departments of Orthopedics (R.V.O., N.N.O., Y.D., G.P.S.) and Surgery (D.M.S.), R Adams Cowley Shock Trauma Center, the University of Maryland School of Medicine, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health (K.P.F., T.J.T., A.R.C., K.S., R.C.C.), the Department of Surgery, John Hopkins Hospital (E.R.H.), and the PREVENT CLOT Patient and Stakeholder Committee (D.M.) - all in Baltimore; the Department of Population Health Science, University of Utah, Salt Lake City (D.O.S.); the Department of Orthopaedic Surgery, Vanderbilt University Medical Center, Nashville (W.O.); the Department of Orthopaedics and Sports Medicine, University of Washington, Seattle (R.F.); the Department of Orthopaedic Surgery, Atrium Health Carolinas Medical Center, Charlotte, NC (M.J.B.); and the Department of Medicine, Harvard Medical School, Boston (S.Z.G.).
• N. Engl. J. Med. 2023 Jan 19; 388 (3): 203213203-213.

BackgroundClinical guidelines recommend low-molecular-weight heparin for thromboprophylaxis in patients with fractures, but trials of its effectiveness as compared with aspirin are lacking.MethodsIn this pragmatic, multicenter, randomized, noninferiority trial, we enrolled patients 18 years of age or older who had a fracture of an extremity (anywhere from hip to midfoot or shoulder to wrist) that had been treated operatively or who had any pelvic or acetabular fracture. Patients were randomly assigned to receive low-molecular-weight heparin (enoxaparin) at a dose of 30 mg twice daily or aspirin at a dose of 81 mg twice daily while they were in the hospital. After hospital discharge, the patients continued to receive thromboprophylaxis according to the clinical protocols of each hospital. The primary outcome was death from any cause at 90 days. Secondary outcomes were nonfatal pulmonary embolism, deep-vein thrombosis, and bleeding complications.ResultsA total of 12,211 patients were randomly assigned to receive aspirin (6101 patients) or low-molecular-weight heparin (6110 patients). Patients had a mean (±SD) age of 44.6±17.8 years, 0.7% had a history of venous thromboembolism, and 2.5% had a history of cancer. Patients received a mean of 8.8±10.6 in-hospital thromboprophylaxis doses and were prescribed a median 21-day supply of thromboprophylaxis at discharge. Death occurred in 47 patients (0.78%) in the aspirin group and in 45 patients (0.73%) in the low-molecular-weight-heparin group (difference, 0.05 percentage points; 96.2% confidence interval, -0.27 to 0.38; P<0.001 for a noninferiority margin of 0.75 percentage points). Deep-vein thrombosis occurred in 2.51% of patients in the aspirin group and 1.71% in the low-molecular-weight-heparin group (difference, 0.80 percentage points; 95% CI, 0.28 to 1.31). The incidence of pulmonary embolism (1.49% in each group), bleeding complications, and other serious adverse events were similar in the two groups.ConclusionsIn patients with extremity fractures that had been treated operatively or with any pelvic or acetabular fracture, thromboprophylaxis with aspirin was noninferior to low-molecular-weight heparin in preventing death and was associated with low incidences of deep-vein thrombosis and pulmonary embolism and low 90-day mortality. (Funded by the Patient-Centered Outcomes Research Institute; PREVENT CLOT ClinicalTrials.gov number, NCT02984384.).Copyright © 2023 Massachusetts Medical Society.

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