Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery
POP-A-RIX
Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice
1 other identifier
observational
997
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2004
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedFebruary 5, 2010
February 1, 2010
2.2 years
February 4, 2010
February 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine an anti-Xa activity value which is predicted of a haemorrhage risk
day 9
Study Arms (1)
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 Criteria
patients with major orthopedic surgery who need prophylactic doses of fondaprinux
You may qualify if:
- patient who need leg major orthopedic surgery
- age \> 18 years
- patient who need prophylactic doses of fondaparinux
You may not qualify if:
- contra-indication to fondaparinux
- renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CHARRET Françoise
Annonay, 07100, France
PEGOIX Michel
Caen, 14000, France
ROSENCHER Nadia
Paris, 75679, France
PETIT Pierre-Yves
Pierre-Bénite, 69495, France
BARRE Jeanne
Reims, 51092, France
MAITRE Anne-Marie
Rouen, 76031, France
BAYLOT Denis
Saint-Etienne, 42013, France
ZUFFEREY Paul
Saint-Etienne, 42100, France
Biospecimen
blood sample for anti-Xaactivity measure
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick MISMETTI, Pr
CHU SAINT-ETIENNE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 4, 2010
First Posted
February 5, 2010
Study Start
September 1, 2004
Primary Completion
December 1, 2006
Study Completion
February 1, 2007
Last Updated
February 5, 2010
Record last verified: 2010-02