Morbid ObesityNCT01064596
Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery
An observational study of Morbid Obesity and Obesity, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morbid Obesity, Obesity, Surgery
- What is being tested?
- blood samples
- How many people
- 40 participants
- Where
- 3 sitesFrance
- Study dates
- Feb 2010to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: obesity patients who need a bariatric surgery
Who may be able to join
- Age ≥ 18 years old
- requiring a bariatric surgery
- requiring an antithrombotics prophylaxis
- having a morbid obesity based on a BMI >40 kg/m2
- having signed the inform consent form
Who cannot join
- contra-indication to fondaparinux
- history of heparin induced thrombopenia (HIT)
- platelets < 100 G/l
- requiring an effective antithrombotic treatment
Trial locations and contacts
3 sites in 1 country.
France3 sites
Assistance Publique - Hôpitaux de Paris
Paris, 75004
Clinique de la Mutualiste
Saint-Etienne, 42013
Chu de Saint-Etienne
Saint-Etienne, 42100
About this study
After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.
Read the detailed description
We proposed a bicentric study cohort of obese patients (BMI > 40 kg/m2) treated by 1 day injection of Fondaparinux 2.5 mg after bypass surgery. Anti-Xa activity of Fondaparinux will be measured 4 times during hospitalisation for each patient to realise a pharmacokinetic modelisation of Fondaparinux. Haemorrhage and thromboembolics events will be collected.
- Conditions
- Morbid Obesity, Obesity, Surgery
- Being tested
- blood samples
- Keywords
- obesity, fondaparinux, surgery, anti-Xa activity
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery
| Study group | Role | What they receive |
|---|---|---|
| blood sample | Patient with 4 blood samples to measure anti-Xa activity Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate pharmacodynamics parameters of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients following a bariatric surgery
Measured: 5 days
Secondary outcomes (2)
To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days
Measured: D5
the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick MISMETTI, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064596
- Sponsor's protocol ID
- 0908104
- Other IDs
- 2009-016417-15, 2009
- Status last verified
- Sep 2014
- First submitted
- 11 Jan 2010
- Last updated
- 26 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery
- ClinicalTrials.gov ID
- NCT01064596
- Acronym / sponsor ID
- 0908104
- Conditions
- Morbid Obesity, Obesity, Surgery
- Keywords
- obesity, fondaparinux, surgery, anti-Xa activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 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.
After bariatric surgery , thromboembolics complications are major cause of mortality. However, in obese patients, thromboprophylaxia is a controversy. Fondaparinux' efficacy is superior to HBPM, and is a good treatment for this population. Pharmacokinetics information with Fondaparinux in this population are rare.
Detailed description
We proposed a bicentric study cohort of obese patients (BMI > 40 kg/m2) treated by 1 day injection of Fondaparinux 2.5 mg after bypass surgery. Anti-Xa activity of Fondaparinux will be measured 4 times during hospitalisation for each patient to realise a pharmacokinetic modelisation of Fondaparinux. Haemorrhage and thromboembolics events will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sample | – | Other: blood samplesPatient with 4 blood samples to measure anti-Xa activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obesity patients who need a bariatric surgery
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- requiring a bariatric surgery
- requiring an antithrombotics prophylaxis
- having a morbid obesity based on a BMI >40 kg/m2
- having signed the inform consent form
Key exclusion criteria (4 listed)
- contra-indication to fondaparinux
- history of heparin induced thrombopenia (HIT)
- platelets < 100 G/l
- requiring an effective antithrombotic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplespatients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery | Other | blood sample |
Primary outcome
To evaluate pharmacodynamics parameters of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients following a bariatric surgery
Time frame: 5 days
2 secondary outcomes
To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days
Time frame: D5
the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days
Time frame: 5 days
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 26 Sep 2014.
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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, MD, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Obesity, run by Centre Hospitalier Universitaire de Saint Etienne at 3 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 5 inclusion and 4 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 26 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 evaluate pharmacodynamics parameters of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients following a bariatric surgery (time frame: 5 days). 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 26 Sep 2014.