Study to Determine Effective Dosing of Fondaparinux in Obese Persons
Withdrawn before enrolling · Phase 1
Conditions studied: Morbid Obesity
In brief
This is a prospective open-label study comparing two dosing regimens of fondaparinux, which is used to prevent deep vein thrombosis, in morbidly obese volunteers.
Key facts
- Study ID
- NCT00346879
- Run by
- Indiana University
- People needed
- 0
- Starts
- 2006-08-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2016-02-23
Who can join
Age: 19 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 19-65 BMI: 35-65 Negative pregnancy test on day of study
You may not qualify if…
- Blood Pressure < or = to 160/90 Temperature > 37.5 C (99.5 F) Nursing a baby Positive pregnancy test on day of study. Medications: History of regular treatment with anticoagulants or any anti-platelet agents including aspirin and other NSAIDS; use of aspirin or other NSAIDS within 1 month of study.
- Past Medical History:
- Cerebrovascular accident (including transient ischemic attacks) within 6 months of study.
- Diabetic retinopathy as documented by positive fundoscopy in previous 3 months. Active peptic ulcer disease, by EGD or Ba meal, within 3 months of study. Known bleeding disorder. Known thrombophilia History of heparin induced thrombocytopenia. History of bacterial endocarditis. Known hypersensitivity to fondaparinux. Ulcerative colitis. History of GI bleeding History of hematuria Recent surgery (in previous 3 months). Recent trauma - road traffic accident (previous 3 months).
- Laboratory Values:
- Platelet count < or = to 100,000. Hemoglobin <12g/dl - women or <14g/dl - men. Prothrombin time > 13s Activated partial thromboplastin time (APTT) > 35s Liver function test parameters: ALT > 60u/L, AST > 40u/L, γ-GT >85u/L, Alkaline phosphatase >251 u/L or total bilirubin > 1.3 mg/dl.
- Estimated urinary creatinine clearance < 50 mls/min. Hematuria on urine dipstick.
Where it is running
- Clarian Bariatric Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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