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Primary study

Unclassified

Registry of Trials clinicaltrials.gov
Year 2012
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This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.

Primary study

Unclassified

Auteurs Kim SM , Moon YW , Lim SJ , Kim DW , Park YS
Journal Thrombosis and haemostasis
Year 2016
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This prospective study was conducted to report the effect of oral factor Xa inhibitor and low-molecular-weight heparin (LMWH) on surgical complications following total hip arthroplasty (THA). The patients with an age < 60 years were randomly assigned to three groups (rivaroxaban, enoxaparin, and placebo) and the patients with an age ≥ 60 years were assigned to two groups (rivaroxaban and enoxaparin). All drug regimens started at 12 hours postoperatively and continued for two weeks after surgery. Primary measure outcome was major surgical wound complications defined as haematoma requiring any intervention, superficial wound infection, deep periprosthetic infection, and increased wound bleeding. Secondary measured outcome included minor surgical complications (swelling, drainage, erythema, and oozing), organ bleeding, and venous thromboembolic (VTE) events. A total of 184 patients aged < 60 years and 167 patients aged ≥ 60 years were included as the analysis population per group. Up to 14 days after surgery, the overall incidence of major surgical complications associated with thromboprophylaxis was 6.5 % (58/886). There were no significant differences in the rate of major surgical complications among all the three groups of the patients aged < 60 years and between two groups of the patients aged ≥ 60 years. For the patients aged < 60 years, wound oozing continued significantly longer in the pharmacological group than in the placebo group, but wound infection did not occur in any case. The VTE events were similar in all the groups.