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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01064596
First received: January 11, 2010
Last updated: September 25, 2014
Last verified: September 2014
  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 ] [ 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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Assistance Publique - Hôpitaux de Paris
Paris, France, 75004
Chu de Saint-Etienne
Saint-etienne, France, 42100
Clinique de la Mutualiste
Saint-etienne, France, 42013
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: September 25, 2014
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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Fondaparinux
PENTA
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014