Status:
WITHDRAWN
Study to Determine Effective Dosing of Fondaparinux in Obese Persons
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
American Society for Bariatric Surgery
Conditions:
Morbid Obesity
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
The incidence of obesity is growing at an alarming pace and has reached epidemic proportions. Subjects who are more than 100 pounds over their ideal body weight are classified as being morbidly obese ...
Eligibility Criteria
Inclusion
- \- Age 19-65 BMI: 35-65 Negative pregnancy test on day of study
Exclusion
- \- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00346879
Start Date
August 1 2006
End Date
January 1 2009
Last Update
February 23 2016
Active Locations (1)
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1
Clarian Bariatric Center
Indianapolis, Indiana, United States, 46278