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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01064596

Enrollment

Registered

2010-02-08

Start date

2010-02-28

Completion date

2014-05-31

Last updated

2014-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Obesity, Surgery

Keywords

obesity, fondaparinux, surgery, anti-Xa activity

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.

Interventions

OTHERblood samples

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026