Major Orthopaedic Surgery and Renal Impairment Clinical Trial
Official title:
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention