Prophylaxis, Diagnosis and Therapy of Surgery-Related Complications in Orthopedic and Trauma Surgery An Observational Survey (CHANGE)

摘要

Background and Purpose: Selective factor Xa inhibition by the synthetic pentasaccharidefondaparinux is an efficient way of preventing venous thrombosis. Fonda-parinux has been shown to reduce the incidence of venous thromboembolism (VTE) by 50% compared with the low-molecular-weight heparin enoxaparin.The aim of the CHANGE study was to evaluate the management of thrombosis prevention with fondaparinux, and the diagnosis and treatment of complications following major orthopedic surgery.Patients and Methods: Nationwide observational study ("CHANGE") in in centers in Germany. Patients underwent elective knee or hip replacement surgery or surgery on account of fractures of the hip or lower limb. Results: In total, 8,331 patients were documented,of which 7,787 were suitable for analysis.The mean age was 68.5 years; for 50.8% of the patients additional risk factors for VTE were reported.The most frequent main diagnoses by ICDio were coxarthrosis (41.8%), gonar-throsis (32.8%), and fracture of femur (16.7%). 52.6% of the patients underwent hip surgery, 35.3% knee surgery, and 11.5% surgery for fractures.The mean hospital stay lasted 18 days, with only small differences between the different types of surgery.The overall complication rate was 1.68% (n = 131,95% confidence interval [Cl]: 1.42/1.99) with 0.47% VTE (n = 37,95% Cl: 0.34/0.65,31 deep vein thromboses, five pulmonary embolisms, one not specified) and 1.2% bleedings (n = 94,95% Cl: 0.99/1.47). Most of the bleedings occurred in the surgical field.The bleeding rate was highest in the knee surgery group, and also VTE occurred more frequently following knee surgery. During the whole study, no heparin-induced thrombocytopenia was observed. Conclusion: The observational study CHANGE confirms the results of the published preauthorization studies with fondaparinux, with a complication rate nearly half that previously reported. Using fondaparinux for the prevention of VTE leads to improved quality of care in orthopedic patients.