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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064596
• Other study ID #: 0908104
• Secondary ID: 2009-016417-15
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2010
• Last updated: September 25, 2014
• Start date: February 2010
• Est. completion date: May 2014

Study information

• Verified date: September 2014
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid
• Surgery

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris
France	Chu de Saint-Etienne	Saint-etienne
France	Clinique de la Mutualiste	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days		D5	No
Secondary	the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days		5 days	Yes