Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical Patients
Completed · Early Phase 1
Conditions studied: Deep Venous Thrombosis, Pulmonary Embolism
In brief
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 respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.
Key facts
- Study ID
- NCT00894283
- Run by
- Johns Hopkins University
- People needed
- 198
- Starts
- 2009-06-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2019-06-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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