Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

NCT ID: NCT01063543

Last Updated: 2010-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

997 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Orthopedic Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Saint Etienne

Principal Investigators

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Patrick MISMETTI, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHARRET Françoise

Annonay, , France

Site Status

PEGOIX Michel

Caen, , France

Site Status

ROSENCHER Nadia

Paris, , France

Site Status

PETIT Pierre-Yves

Pierre-Bénite, , France

Site Status

BARRE Jeanne

Reims, , France

Site Status

MAITRE Anne-Marie

Rouen, , France

Site Status

BAYLOT Denis

Saint-Etienne, , France

Site Status

ZUFFEREY Paul

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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0601069

Identifier Type: -

Identifier Source: org_study_id

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