Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

Completed

• Conditions: Orthopedic Surgery

• Registration Number: NCT01063543
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2006-12
• Study Completion: 2007-02
• Status Verified: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Last Update Submitted: 2010-02-04
• Study First Posted: 2010-02-05
• Last Update Posted: 2010-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 997

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine an anti-Xa activity value which is predicted of a haemorrhage risk	day 9

Trial Locations

Locations (8)

ROSENCHER Nadia; 🇫🇷 Paris, France

CHARRET Françoise; 🇫🇷 Annonay, France

PETIT Pierre-Yves; 🇫🇷 Pierre Bénite, France

BAYLOT Denis; 🇫🇷 Saint-etienne, France

MAITRE Anne-Marie; 🇫🇷 Rouen, France

PEGOIX Michel; 🇫🇷 Caen, France

BARRE Jeanne; 🇫🇷 Reims, France

ZUFFEREY Paul; 🇫🇷 Saint-etienne, France