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

NCT01064596 | Completed

• 2 other identifiers: 09081042009-016417-15
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Morbid Obesity; Obesity; Surgery

Keywords

obesity; fondaparinux; surgery; anti-Xa activity

Outcome Measures

Primary Outcomes (1)

• 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

  5 days

Secondary Outcomes (2)

• To evaluate the incidence of symptomatic venous thromboembolics events (DVT and PE) between D5 and D10 and at 1month ± 10 days

  D5

• the incidence of major and clinically significative bleeding between D5 and D10 and at 1 month ± 10 days

  5 days

Study Arms (1)

blood sample

Patient with 4 blood samples to measure anti-Xa activity

Other: blood samples

Interventions

blood samples OTHER

patients with a fondaparinux treatment who have 4 blood samples during the 10 days following surgery

blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

obesity patients who need a bariatric surgery

You may qualify if:

• 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

You may not qualify if:

• contra-indication to fondaparinux
• history of heparin induced thrombopenia (HIT)
• platelets \< 100 G/l
• requiring an effective antithrombotic treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

Assistance Publique - Hôpitaux de Paris

Paris, 75004, France

Location

Clinique de la Mutualiste

Saint-Etienne, 42013, France

Location

Chu de Saint-Etienne

Saint-Etienne, 42100, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

4 blood samples to measure anti-Xa activity

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Patrick MISMETTI, MD, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: February 8, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

FR (3)