Overview

Study to Determine Effective Dosing of Fondaparinux in Obese Persons

Status:
Withdrawn
Trial end date:
2009-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Indiana University School of Medicine
Collaborator:
American Society for Bariatric Surgery
Treatments:
Fondaparinux
PENTA
Criteria
Inclusion Criteria:

- Age 19-65 BMI: 35-65 Negative pregnancy test on day of study

Exclusion Criteria:

- 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.