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Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery (POP-A-RIX)

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01063543
First received: February 4, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 4, 2010
February 4, 2010
September 2004
December 2006   (final data collection date for primary outcome measure)
To determine an anti-Xa activity value which is predicted of a haemorrhage risk [ Time Frame: day 9 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery
Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

blood sample for anti-Xaactivity measure
Non-Probability Sample

patients with major orthopedic surgery who need prophylactic doses of fondaprinux
Orthopedic Surgery
Not Provided
patients with blood sample
Patients with major orthopedic surgery and prophylactic doses of fondaparinux who have 3 blood sample during their hospitalization to measure anti-Xa activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
997
February 2007
December 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient who need leg major orthopedic surgery
  • age > 18 years
  • patient who need prophylactic doses of fondaparinux

Exclusion Criteria:

  • contra-indication to fondaparinux
  • renal insufficiency
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01063543
0601069
No
Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Patrick MISMETTI, Pr CHU SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP