Orthopedic SurgeryPOP-A-RIXNCT01063543
Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery
An observational study of Orthopedic Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Orthopedic Surgery
- How many people
- 997 participants
- Where
- 8 sitesFrance
- Study dates
- Sep 2004to Feb 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with major orthopedic surgery who need prophylactic doses of fondaprinux
Who may be able to join
- patient who need leg major orthopedic surgery
- age > 18 years
- patient who need prophylactic doses of fondaparinux
Who cannot join
- contra-indication to fondaparinux
- renal insufficiency
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHARRET Françoise
Annonay, 07100
PEGOIX Michel
Caen, 14000
ROSENCHER Nadia
Paris, 75679
PETIT Pierre-Yves
Pierre-Bénite, 69495
BARRE Jeanne
Reims, 51092
MAITRE Anne-Marie
Rouen, 76031
BAYLOT Denis
Saint-Etienne, 42013
ZUFFEREY Paul
Saint-Etienne, 42100
About this study
Official title: Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice
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
- Conditions
- Orthopedic Surgery
- Keywords
- fondaparinux, orthopedic surgery, patients with major orthopedic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine an anti-Xa activity value which is predicted of a haemorrhage risk
Measured: day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startSep 2004
- Primary completionDec 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 997 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Patrick MISMETTI, Pr, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063543
- Sponsor's protocol ID
- 0601069
- Acronym
- POP-A-RIX
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics of Fondaparinux Administered at Prophylactic Doses After Major Orthopedic Surgery in Everyday Practice
- ClinicalTrials.gov ID
- NCT01063543
- Acronym / sponsor ID
- POP-A-RIX / 0601069
- Conditions
- Orthopedic Surgery
- Keywords
- fondaparinux, orthopedic surgery, patients with major orthopedic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 997 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with major orthopedic surgery who need prophylactic doses of fondaprinux
Key inclusion criteria (3 listed)
- patient who need leg major orthopedic surgery
- age > 18 years
- patient who need prophylactic doses of fondaparinux
Key exclusion criteria (2 listed)
- contra-indication to fondaparinux
- renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine an anti-Xa activity value which is predicted of a haemorrhage risk
Time frame: day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
Related trials for Orthopedic Surgery
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Enrolling by invitationPhase 4
PPP Versus Corticosteroid for Thigh Muscle Injuries
Thigh Muscle Injury, Thigh Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick MISMETTI, Pr principal investigator
Centre Hospitalier Universitaire de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine an anti-Xa activity value which is predicted of a haemorrhage risk (time frame: day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2010.