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

Sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by (Responsible Party):	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT01064596

Purpose

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	Intervention	Phase
Morbid Obesity Obesity Surgery	Other: blood samples	Phase IV

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Loss Surgery

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days [ Time Frame: D5 ] [ Designated as safety issue: No ]
the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

4 blood samples to measure anti-Xa activity

Estimated Enrollment:	100
Study Start Date:	February 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

obesity patients who need a bariatric surgery

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064596

Contacts

Contact: Anne GODIER, MD

anne.godier@htd.aphp.fr

Locations

France
Assistance Publique - Hôpitaux de Paris	Recruiting
Paris, France, 75004
Contact: Anne GODIER, MD anne.godier@htd.aphp.fr
Principal Investigator: Anne GODIER, MD
Clinique de la Mutualiste	Not yet recruiting
Saint-etienne, France, 42013
Contact: Denis BAYLOT, MD dbaylot@mutualite-loire.com
Principal Investigator: Denis BAYLOT, MD
Chu de Saint-Etienne	Not yet recruiting
Saint-etienne, France, 42100
Contact: Patrick MISMETTI, MD, PhD
Principal Investigator: Patrick MISMETTI, MD PhD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator:

Patrick MISMETTI, MD, PhD

CHU SAINT-ETIENNE

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT01064596 History of Changes
Other Study ID Numbers:	0908104, 2009-016417-15
Study First Received:	January 11, 2010
Last Updated:	November 10, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

obesity
fondaparinux
surgery
anti-Xa activity

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Fondaparinux
PENTA

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012