Status:
COMPLETED
Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Deep Venous Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respe...
Detailed Description
In order to determine the feasibility of such a trial we need to determine the necessary sample size. In order to determine the necessary sample size, we need to obtain estimates of the incidence of D...
Eligibility Criteria
Inclusion
- Men or women 18 years or older.
- Body mass index (BMI) of 35kg/m2 or greater.
- Undergoing laparoscopic bariatric surgery, i.e., laparoscopic sleeve gastrectomy, laparoscopic Roux-en Y gastric bypass or laparoscopic duodenal switch.
Exclusion
- History of previous deep vein thrombosis.
- History of previous pulmonary emboli.
- History of documented clotting/coagulation disorder.
- History of cancer.
- Weight \< 50 kg or \> 200 kg or unable to fit in MRI scanner.
- Presence of metallic foreign bodies
- Recent history of smoking (within the last year).
- History of venous stasis disease.
- History of obesity hypoventilation syndrome.
- Patients who are unable to lay flat for extended periods of time or are claustrophobic.
- Patients who have a pacemaker, an implanted defibrillator or certain other implanted or electronic or metallic devices (implanted medical or metallic devices, shrapnel, or metal).
- History of hypersensitivity reaction to anticoagulation products.
- History of HIT (Heparin Induced Thrombocytopenia.
- History of Renal Insufficiency (Creatinine Clearance \< 50).
- Active clinically significant bleeding.
- Acute bacterial endocarditis.
- BMI \> 60.
- Patients with metallic foreign body or implant (unable to have an MRV study).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00894283
Start Date
June 1 2009
End Date
September 1 2013
Last Update
June 7 2019
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224