Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.