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
Overview
- Phase
- Early Phase 1
- Intervention
- Enoxaparin
- Conditions
- Deep Venous Thrombosis
- Sponsor
- Johns Hopkins University
- Enrollment
- 198
- Locations
- 1
- Primary Endpoint
- To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.
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 DVT and the prevalence of PE using MRV in each treatment group. Descriptive statistics and 95% confidence intervals will be calculated to determine the incidence of DVT and the prevalence of PE using MRV in obese patients who have received treatment to prevent DVT and PE associated with bariatric surgery. Anti-factor Xa levels will be used to help determine if treatments are reaching appropriate levels.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Enoxaparin
Patients will receive enoxaparin 40mg subcutaneously twice daily during perioperative period of bariatric surgery. Patients will be encouraged to ambulate and compression stockings while in bed.
Intervention: Enoxaparin
Fondaparinux
Fondaparinux 5mg subcutaneously 6 hours following surgery, fondaparinux 5mg subcutaneously once daily during hospitalization. Patients will be encouraged to ambulate and compression stockings while in bed.
Intervention: Fondaparinux
Outcomes
Primary Outcomes
To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
Time Frame: 2 years
Secondary Outcomes
- 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)