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| Descriptive Information Fields | |||||
| Brief Title † | Prospective, Multicentre, Open-Label Study Evaluating 1,5 mg/Day of Fondaparinux. | ||||
| 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 | ||||
| Brief 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. |
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| Detailed 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 |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | evaluate between Day 1 and Day 10, the incidence of major bleedings. [ Time Frame: 45 day ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | evaluate the incidence of major bleedings at 1 month ± 5 days, of symptomatic DVT and PE between Day 1 and Day 10 and at 1 month ± 5 days and Pharmacokinetic parameters [ Time Frame: 45 day ] [ Designated as safety issue: Yes ] | ||||
| Condition † | Major Orthopaedic Surgery and Renal Impairment | ||||
| Intervention † | Drug: fondaparinux 1,5 mg/day | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 451 | ||||
| Start Date † | June 2007 | ||||
| Completion Date | October 2008 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | France | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00555438 | ||||
| Organization ID | 0701017 | ||||
| Secondary IDs †† | EudraCT number 2007-001048-32 | ||||
| Study Sponsor † | Centre Hospitalier Universitaire de Saint Etienne | ||||
| Collaborators †† | GlaxoSmithKline | ||||
| Investigators † |
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| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||
| Verification Date | October 2008 | ||||
| First Received Date † | November 7, 2007 | ||||
| Last Updated Date | October 13, 2008 | ||||
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