Phase 4 N=442 Prevention

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

Major Orthopaedic Surgery and Renal Impairment

Bottom Line

View on ClinicalTrials.gov: NCT00555438 ↗

Enrolled (actual)

442

Serious AEs

7.2%

Results posted

Nov 2010

Primary outcome: Primary: Number of Patients With Major Bleedings Between Day 1 and Day 10. — 20 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: fondaparinux 1.5 mg/day (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Major Bleedings Between Day 1 and Day 10.	20	—
SECONDARY Number of Patients With Major Bleedings at 1 Month ± 5 Days.	23	—
SECONDARY Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10	2	—
SECONDARY Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days	3	—
SECONDARY Death at 1 Month ± 5 Days	10	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00555438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.