Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux. (PROPICE)

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Major Orthopaedic Surgery and Renal Impairment

Treatments: Drug: fondaparinux 1.5 mg/day

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00555438

0701017

2007-001048-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 451 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • age > 18 years old,

  • undergoing a major orthopaedic surgery (THR, TKR, HF) whatever procedure techniques are used, 1st indication or 2nd indication,
  • requiring an antithrombotic prophylaxis,
  • presenting a renal impairment defined by a creatinin clearance (CrCl) between 20 and 50 ml/min calculated by Cockcroft and Gault's formula,
  • having signed the inform consent form.

Exclusion criteria

• contra-indications to fondaparinux,
• history of heparin inducted thrombopenia (HIT),
• platelets < 100 g/l.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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451 participants in 1 patient group

1

Experimental group

Description:

patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery

Treatment:

Drug: fondaparinux 1.5 mg/day