Phase 4
Completed N=442
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux.
Major Orthopaedic Surgery and Renal Impairment
Source: ClinicalTrials.gov NCT00555438 ↗
Enrolled (actual)
442
Serious AEs
7.2%
Results posted
Nov 2010
Primary outcomePrimary: Number of Patients With Major Bleedings Between Day 1 and Day 10. — 20 participants
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.
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 | — |
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.
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. Informational only — not medical advice.