Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery (POP-A-RIX)
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Purpose
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
| Condition |
|---|
|
Orthopedic Surgery |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice |
- To determine an anti-Xa activity value which is predicted of a haemorrhage risk [ Time Frame: day 9 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
blood sample for anti-Xaactivity measure
| Enrollment: | 997 |
| Study Start Date: | September 2004 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
patients with major orthopedic surgery who need prophylactic doses of fondaprinux
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
Contacts and Locations| France | |
| CHARRET Françoise | |
| Annonay, France, 07100 | |
| PEGOIX Michel | |
| Caen, France, 14000 | |
| ROSENCHER Nadia | |
| Paris, France, 75679 | |
| PETIT Pierre-Yves | |
| Pierre Bénite, France, 69495 | |
| BARRE Jeanne | |
| Reims, France, 51092 | |
| MAITRE Anne-Marie | |
| Rouen, France, 76031 | |
| ZUFFEREY Paul | |
| Saint-etienne, France, 42100 | |
| BAYLOT Denis | |
| Saint-etienne, France, 42013 | |
| Principal Investigator: | Patrick MISMETTI, Pr | CHU SAINT-ETIENNE |
More Information
No publications provided
| Responsible Party: | Pr Patrick MISMETTI, Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT01063543 History of Changes |
| Other Study ID Numbers: | 0601069 |
| Study First Received: | February 4, 2010 |
| Last Updated: | February 4, 2010 |
| Health Authority: | France: French Data Protection Authority |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
fondaparinux orthopedic surgery patients with major orthopedic surgery |
Additional relevant MeSH terms:
|
Fondaparinux PENTA Anticoagulants Hematologic Agents Therapeutic Uses |
Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013