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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01063543
First Posted: February 5, 2010
Last Update Posted: February 5, 2010
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.
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
  Purpose
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
Orthopedic Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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

Enrollment: 997
Study Start Date: September 2004
Study Completion Date: February 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01063543


Locations
France
CHARRET Françoise
Annonay, France, 07100
PEGOIX Michel
Caen, France, 14000
ROSENCHER Nadia
Paris, France, 75679
PETIT Pierre-Yves
Pierre Bénite, France, 69495
BARRE Jeanne
Reims, France, 51092
MAITRE Anne-Marie
Rouen, France, 76031
BAYLOT Denis
Saint-etienne, France, 42013
ZUFFEREY Paul
Saint-etienne, France, 42100
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Patrick MISMETTI, Pr CHU SAINT-ETIENNE
  More Information

Responsible Party: Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01063543     History of Changes
Other Study ID Numbers: 0601069
First Submitted: February 4, 2010
First Posted: February 5, 2010
Last Update Posted: February 5, 2010
Last Verified: February 2010

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

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