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Prospective, Multicentre, Open-Label Study Evaluating 1,5 mg/Day of Fondaparinux. (PROPICE)

This study has been completed.
Study NCT00555438.   Last updated on October 13, 2008.   Information provided by Centre Hospitalier Universitaire de Saint Etienne

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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.

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

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:

  • • 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.
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 
Principal Investigator:     MISMETTI Patrick, MD     CHU SAINT-ETIENNE    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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