Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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

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Morbid Obesity Obesity Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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blood sample

Patient with 4 blood samples to measure anti-Xa activity

blood samples

Intervention Type OTHER

patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery

Interventions

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blood samples

patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* contra-indication to fondaparinux
* history of heparin induced thrombopenia (HIT)
* platelets \< 100 G/l
* requiring an effective antithrombotic treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No