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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Conditions

Surgery
Obesity
Morbid Obesity

Treatments

Other: blood samples

Study type

Observational

Funder types

Other

Identifiers

NCT01064596
2009-016417-15 (EudraCT Number)
0908104

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

blood sample
Description:
Patient with 4 blood samples to measure anti-Xa activity
Treatment:
Other: blood samples

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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