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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01064596
First Posted: February 8, 2010
Last Update Posted: September 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  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 4

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:


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 ]

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 ]
  • the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days [ Time Frame: 5 days ]

Biospecimen Retention:   Samples Without DNA
4 blood samples to measure anti-Xa activity

Enrollment: 40
Study Start Date: February 2010
Study Completion Date: May 2014
Primary Completion Date: April 2014 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064596


Locations
France
Assistance Publique - Hôpitaux de Paris
Paris, France, 75004
Clinique de la Mutualiste
Saint-etienne, France, 42013
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
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT01064596     History of Changes
Other Study ID Numbers: 0908104
2009-016417-15 ( EudraCT Number )
First Submitted: January 11, 2010
First Posted: February 8, 2010
Last Update Posted: September 26, 2014
Last Verified: September 2014

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
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents