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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063543
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : February 5, 2010
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:
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

Condition or disease
Orthopedic Surgery

Study Type : Observational
Actual Enrollment : 997 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice
Study Start Date : September 2004
Primary Completion Date : December 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. To determine an anti-Xa activity value which is predicted of a haemorrhage risk [ Time Frame: day 9 ]

Biospecimen Retention:   Samples Without DNA
blood sample for anti-Xaactivity measure

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with major orthopedic surgery who need prophylactic doses of fondaprinux

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063543

CHARRET Françoise
Annonay, France, 07100
Caen, France, 14000
Paris, France, 75679
PETIT Pierre-Yves
Pierre Bénite, France, 69495
BARRE Jeanne
Reims, France, 51092
MAITRE Anne-Marie
Rouen, France, 76031
Saint-etienne, France, 42013
Saint-etienne, France, 42100
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Principal Investigator: Patrick MISMETTI, Pr CHU SAINT-ETIENNE

Responsible Party: Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT01063543     History of Changes
Other Study ID Numbers: 0601069
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: February 2010

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
orthopedic surgery
patients with major orthopedic surgery

Additional relevant MeSH terms:
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents