Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01063543

Acronym

POP-A-RIX

Enrollment

997

Registered

2010-02-05

Start date

2004-09-30

Completion date

2007-02-28

Last updated

2010-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Surgery

Keywords

fondaparinux, orthopedic surgery, patients with major orthopedic surgery

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results