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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 7, 2007 | ||||
| Last Updated Date | October 13, 2008 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
evaluate between Day 1 and Day 10, the incidence of major bleedings. [ Time Frame: 45 day ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
evaluate between Day 1 and Day 10, the incidence of major bleedings. [ Time Frame: 45 day ] | ||||
| Change History | Complete list of historical versions of study NCT00555438 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prospective, Multicentre, Open-Label Study Evaluating 1,5 mg/Day of Fondaparinux. | ||||
| Official Title ICMJE | 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 ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Major Orthopaedic Surgery and Renal Impairment | ||||
| Intervention ICMJE | Drug: fondaparinux 1,5 mg/day | ||||
| Study Arms / Comparison Groups | Experimental: patients with renal impairment who received Fondaparinux 1,5 mg/l after major orthopaedic surgery | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 451 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00555438 | ||||
| Responsible Party | Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne | ||||
| Study ID Numbers ICMJE | 0701017, EudraCT number 2007-001048-32 | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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