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

This study is currently recruiting participants.
Verified November 2012 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01064596
First received: January 11, 2010
Last updated: November 22, 2012
Last verified: November 2012
History of Changes
  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:

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: January 2015
Estimated Primary Completion Date: December 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

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 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 June 17, 2013