Pulmonary Embolism Clinical Trial
Official title:
A Pilot Study 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 VTE After Bariatric Surgery in Obese Patients
Verified date | June 2019 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 198 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Men or women 18 years or older. 2. Body mass index (BMI) of 35kg/m2 or greater. 3. Undergoing laparoscopic bariatric surgery, i.e., laparoscopic sleeve gastrectomy, laparoscopic Roux-en Y gastric bypass or laparoscopic duodenal switch. Exclusion Criteria: 1. History of previous deep vein thrombosis. 2. History of previous pulmonary emboli. 3. History of documented clotting/coagulation disorder. 4. History of cancer. 5. Weight < 50 kg or > 200 kg or unable to fit in MRI scanner. 6. Presence of metallic foreign bodies 7. Recent history of smoking (within the last year). 8. History of venous stasis disease. 9. History of obesity hypoventilation syndrome. 10. Patients who are unable to lay flat for extended periods of time or are claustrophobic. 11. 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). 12. History of hypersensitivity reaction to anticoagulation products. 13. History of HIT (Heparin Induced Thrombocytopenia. 14. History of Renal Insufficiency (Creatinine Clearance < 50). 15. Active clinically significant bleeding. 16. Acute bacterial endocarditis. 17. BMI > 60. 18. Patients with metallic foreign body or implant (unable to have an MRV study). |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery. | 2 years | ||
Secondary | To assess the relationship of Anti-factor Xa levels and the occurrence of deep venous thrombosis and pulmonary emboli in bariatric patients receiving standard dose of anticoagulation (enoxaparin/Lovenox or fondaparinux/Arixtra). | 2 years |
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