Status:
COMPLETED
Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Venous Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication ...
Detailed Description
Bariatric surgery carries a mortality rate of 0.5-1%, with PE found to be the most frequent postoperative complications and causes of death. Currently employed prophylactic methods include unfractiona...
Eligibility Criteria
Inclusion
- INCLUSION
- Age 19-65 years
- BMI 35-65 Kg/m2
- Pregnancy test Negative on day of study
- Past DVT/PE/MI These patients will not be excluded providing they are not on current therapy with anticoagulants, aspirin, or anti-platelet agents.
- EXCLUSION
- BP ≥ 160/90
- Temperature \> 37.5 0C (99.5 0F)
- Nursing mothers Exclude if nursing
- Pregnancy test Positive on day of study
- Medications Anticoagulants, anti-platelet agents, aspirin, NSAIDs within a month of the study
- Past medical history
- cerebrovascular accident (including TIA within 6 months of the study)
- Diabetic retinopathy proven by fundoscopy
- History of inherited thrombotic/hypercoagulable defect
- Active peptic ulcer disease diagnosed by upper endoscopy
- Known bleeding disorder, 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 (last 3 months)
- Recent trauma (last 3 months)
- Laboratory values
- Platelet count ≤ 100,000 mm3
- Hemoglobin \< 12 g/dL (women), or \< 14 g/dL (men)
- Prothrombin time \> 13 sec
- PTT \> 35 sec
- ALT 3xULN and bilirubin 1.5xULN (\>35% direct); or ALT 5xULN; or ALT 3xULN if associated with the appearance or worsening of hepatitis symptoms or rash
- Estimated urinary creatinine clearance ≤ 50 ml/min
- Hematuria on urine dipstick
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00436787
Start Date
February 1 2007
End Date
December 1 2007
Last Update
May 16 2008
Active Locations (2)
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1
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
2
Shadyside Medical Building
Pittsburgh, Pennsylvania, United States, 15232