A prospective observational study on the effectiveness and safety of bemiparin, first dose administered 6 h after knee or hip replacement surgery

Abstract

Introduction: Bemiparin has shown to be effective and safe in clinical trials in total knee or hip replacement. Materials and methods: We conducted a prospective, open, multicentre, uncontrolled study to audit the utilisation patterns of bemiparin 3,500 IU/day, first dose administered 6 h after surgery, in 1,009 patients undergoing total hip or knee replacement surgery in standard clinical practice. We analysed rates of documented symptomatic venous thromboembolism (VTE) [deep-vein thrombosis (DVT) and pulmonary embolism (PE)] confirmed by objective methods, major bleeding, death, thrombocytopaenia and other adverse events up to 6 weeks. Results: Rate of documented symptomatic DVT was 0.3% (95% CI, 0.1-0.9%). No cases of documented PE were reported. There were 14 (1.4%) major bleedings (95% CI, 0.8-2.3%). Neuraxial anaesthesia was used in 937 (92.9%) patients. There were no cases of spinal haematoma, fatal bleeding or bleeding in critical organs. There were 6 (0.6%) cases of mild thrombocytopaenia, which did not require treatment discontinuation. No cases of severe type II heparin-induced thrombocytopaenia were observed. There were no deaths during bemiparin prophylaxis. The median length of hospitalisation was 9 days and 92.5% of patients continued prophylaxis post-hospitalisation for a total median time of 38 days. There were no thromboembolic or bleeding complications during post-hospitalisation prophylaxis. Postoperative start of prophylaxis with bemiparin permitted that 29.3% of patients could be admitted to hospital the same day of the intervention. Conclusion: Bemiparin prophylaxis, started 6 h after surgery and given for 5-6 weeks after total hip or knee replacement, was associated with low rates of VTE, major bleeding and other adverse events in normal clinical practice. Bemiparin thromboprophylaxis started 6 h after surgery makes neuraxial anaesthesia/analgesia procedures easier, without compromising efficacy. © Springer-Verlag 2006.