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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01064596
• Collaborator: (none)
• Enrollment: 40
• Locations: 3
• Duration (Months): 50.9
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity; Obesity; Surgery	Other: blood samples

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 Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
blood sample Patient with 4 blood samples to measure anti-Xa activity	Other: blood samples; patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery

Outcome Measures

Primary Outcome Measures

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 [5 days]

Secondary Outcome Measures

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

2. the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days [5 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique - Hôpitaux de Paris	Paris		France	75004
2	Clinique de la Mutualiste	Saint-etienne		France	42013
3	Chu de Saint-Etienne	Saint-etienne		France	42100

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

Investigators

• Principal Investigator: Patrick MISMETTI, MD, PhD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT01064596
• Other Study ID Numbers: 0908104; 2009-016417-15
• First Posted: Feb 8, 2010
• Last Update Posted: Sep 26, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: obesity; fondaparinux; surgery; anti-Xa activity
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Sep 26, 2014