obese patients MedDRA version: 12.0 Level: LLT Classification code 10027966 Term: Morbid obesity MedDRA version: 12.0 Level: LLT Classification code 10059610 Term: Obesity surgery
Conditions
Interventions
Trade Name: Arixtra 2,5 mg/0,5ml
Pharmaceutical Form: Solution for injection
CAS Number: 0
Other descriptive name: FONDAPARINUX
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
CHU de SAINT-ETIENNE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years old - requiring a bariactric surgery - requiring an antithrombotics prophylaxis - having a morbid obesity based on a BMI >40 kg/m2 - having signed the inform consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - contra-indication to fondaparinux - history of heparin induced thrombopenia (HIT) - platelets < 100 G/l - requiring an effective antithrombotic treatment - aptients with justice protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate pharmacodynamics parameters (absorption and elimination half life, clearance, distribution volume and their variability) of fondaparinux based on anti-Xa activity estimated by a non linear model at mixed effect of obese morbid patients (BMI >40kg/m2) with a daily subcutaneous injection of fondaparinux 2,5 mg during at least 5 days following a bariatric surgery;Secondary Objective: To evaluate: - the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1 month ± 10 days - the incidence of major and clinicaly significative bleeding between D5 and D10 and at 1 month ± 10 days ;Primary end point(s): Fondaparinux plasmatic concentration based on anti-Xa activity mesured by colorimetric method | — |
Countries
France
Outcome results
None listed