Is Therapeutic Anticoagulation Necessary for the Treatment of Distal Deep Venous Thrombosis of the Lower Extremity? A Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Deep Vein Thrombosis Resolution
研究概览
简要总结
Hospitalized patients are at risk of developing blood clots in the legs (Deep Vein Thrombosis or DVT), which can lead to death if those clots break off and migrate to the lungs. We know that if there is a blood clot in the large leg veins near the hips and in the thighs, treating these patients with high-doses of blood thinners reduces the risk of these deaths.
It is unclear if treating blood clots in the calf with high doses of blood thinners is better than using low doses. In this study, after being diagnosed with a blood clot in the calf, patients will be treated with either low dose or high dose enoxaparin (Lovenox), a blood thinner. We will then see if low dose blood thinner has similar results as high dose blood thinner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 18 admitted to a trauma or general surgery service will be eligible
- •Patients diagnosed with an isolated distal DVT
- •Able to obtain informed consent
排除标准
- •Patients with a previous diagnosis of hypercoagulability
- •Patients on chronic anticoagulation
- •Patients with a history of heparin induced thrombocytopenia
- •Patients have preexisting contraindications to anticoagulation
- •Patients in renal failure requiring adjusted enoxaparin dosing
- •Pregnant patients
研究组 & 干预措施
Low Dose Enoxaparin
Subjects are randomized to receive or begin prophylactic dosing (30 mg BID) of enoxaparin for 6 weeks or until DVT resolution.
干预措施: Low Dose Enoxaparin (Drug)
High Dose Enoxaparin
Subjects are randomized to begin therapeutic dosing (1 mg/kg body weight BID) of enoxaparin for 6 weeks or until DVT resolution.
干预措施: High Dose Enoxaparin (Drug)
结局指标
主要结局
Deep Vein Thrombosis Resolution
时间窗: 6 weeks
Evaluation of DVT resolution
次要结局
未报告次要终点
研究者
Martin A Schreiber, MD
Professor & Chief of Trauma
Oregon Health and Science University