Skip to main content
OpenTrials
Completed

NCT Number: NCT01064596

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique - Hôpitaux de Paris, Paris, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days

    Time frame: D5

  2. the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2010
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.