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

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.