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NCT01063543 Clinical Trial

Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

Orthopedic Surgery Clinical Trial

— POP-A-RIX  

Official title:
Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01063543
Other study ID # 0601069
Secondary ID
Status Completed
Phase N/A
First received February 4, 2010
Last updated February 4, 2010
Start date September 2004
Est. completion date February 2007

Study information
Verified date February 2010
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection Authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 997
Est. completion date February 2007
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France CHARRET Françoise Annonay
France PEGOIX Michel Caen
France ROSENCHER Nadia Paris
France PETIT Pierre-Yves Pierre Bénite
France BARRE Jeanne Reims
France MAITRE Anne-Marie Rouen
France BAYLOT Denis Saint-etienne
France ZUFFEREY Paul Saint-etienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine an anti-Xa activity value which is predicted of a haemorrhage risk day 9 Yes
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