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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Patients with metallic foreign body or implant (unable to have an MRV study).
研究组 & 干预措施
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.
干预措施: Enoxaparin (Drug)
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.
干预措施: Fondaparinux (Drug)
结局指标
主要结局
To estimate the prevalence of asymptomatic deep venous thrombosis and pulmonary emboli in obese patients undergoing bariatric surgery.
时间窗: 2 years
次要结局
- 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)