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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 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 6, 2013
Last verified: November 2013

January 11, 2010
November 6, 2013
February 2010
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01064596 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery
Fondaparinux Population Pharmacokinetic to Morbid Obese Patients in Post-operatory Bariatric Surgery

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

4 blood samples to measure anti-Xa activity

Non-Probability Sample

obesity patients who need a bariatric surgery

  • Morbid Obesity
  • Obesity
  • Surgery
Other: blood samples
patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery
blood sample
Patient with 4 blood samples to measure anti-Xa activity
Intervention: Other: blood samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Anne GODIER, MD anne.godier@htd.aphp.fr
France
 
NCT01064596
0908104, 2009-016417-15
No
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Patrick MISMETTI, MD, PhD CHU SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP