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

Completed

• Conditions: Surgery; Obesity; Morbid Obesity
• Interventions: Other: blood samples

• Registration Number: NCT01064596
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

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 Timeline

• Study First Submitted: 2010-01-11
• Study Start: 2010-02
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2014-04
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-25
• Last Update Posted: 2014-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
blood sample	blood samples	Patient with 4 blood samples to measure anti-Xa activity

Primary Outcome Measures

Name	Time	Method
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	5 days

Secondary Outcome Measures

Name	Time	Method
To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days	D5
the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days	5 days

Trial Locations

Locations (3)

Clinique de la Mutualiste; 🇫🇷 Saint-etienne, France

Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France

Chu de Saint-Etienne; 🇫🇷 Saint-etienne, France