Conditions: Major Orthopaedic Surgery and Renal Impairment
Keywords: major orthopaedic surgery venous thromboembolic events prevention renal impairment Arixtra anti-Xa activity
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 451
Healthy volunteers: no

Brief summary:
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.

prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.

Detailed description:
Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.

Screening visit : \> 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days

Arms:
arm 1: patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery

Interventions: intervention 1: fondaparinux 1.5 mg/day
Intervention descriptions: intervention 1: Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery

Protocol document: