Once Daily Enoxaparin for Outpatient Treatment of Acute Deep Venous Thrombosis and/or Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Major Bleeding Complication
研究概览
简要总结
To investigate the efficacy and safety of once daily enoxaparin as a "bridge" to warfarin for the outpatient treatment of acute deep venous thrombosis or pulmonary embolism.
详细描述
Background and Significance:
Low molecular weight heparin (LMWH) as a "bridge" to warfarin has become the standard of care for outpatient treatment of acute deep venous thrombosis (DVT). LMWH is also often prescribed as a "bridge" to warfarin for patients with acute pulmonary embolism (PE). In the United States, the FDA has approved enoxaparin only for twice daily dosing in outpatient treatment of acute DVT. The FDA has also approved enoxaparin for treatment of DVT with or without PE, but the FDA has not approved enoxaparin for the treatment of PE without DVT. The FDA has also not approved once daily enoxaparin for any DVT or PE treatment indication for outpatients.
Once daily dosing of enoxaparin in outpatients with DVT alone, DVT with PE, or PE without DVT will halve the number of required injections, facilitate outpatient treatment, and reduce health care costs. For example, visiting nurses will make one visit daily instead of two visits daily for those patients who are unable self-inject and for those patients who lack family or friends to inject LMWH.
Merli et al randomized 900 hospitalized venous thromboembolism (VTE) patients with acute DVT or PE to one of three treatment groups: 1) continuous infusion of unfractionated heparin (UFH), 2) once daily enoxaparin 1.5mg/kg, or 3) twice daily enoxaparin 1mg/kg. All study patients were inpatients. None were outpatients. They received once or twice daily enoxaparin or UFH for at least five days and were "bridged" to warfarin. Patients were followed for three months. Primary endpoints were recurrent DVT or PE. There were no significant differences in recurrent DVT or PE among the 3 treatment groups. There were 12 recurrent VTE events in the UFH group, 13 in the once daily enoxaparin group, and 9 in the twice daily enoxaparin group.
The frequency of major hemorrhage did not differ among the three treatment groups. Major hemorrhage occurred in 6 of 290 patients (2.1%) in the UFH group, 5 of 298 patients (1.7%) in the once daily enoxaparin group, and 4 of 312 patients (1.3%) in the twice daily enoxaparin group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan.
- •Pulmonary embolism patients with normal right ventricular size on chest CT scan.
- •Age greater than 18 years
- •Anticipated discharge within 72 hours of admission
- •Written informed consent
排除标准
- •Pregnancy or intend to become pregnant
- •Patients requiring ongoing hospitalization > 72 hours
- •Hypersensitivity to heparin, pork products or enoxaparin
- •Creatinine > 2.0 mg/dl
- •Recurrent DVT and/or PE with oral anticoagulation
- •Surgery or medical procedure planned during the study that may pose a significant bleeding risk
- •Prior history of heparin-induced thrombocytopenia
- •Inability to participate for follow up appointments and study visits
- •Life expectancy < 30 days
- •High risk of bleeding:
- •Active major bleeding within 30 days by GUSTO criteria
- •History of intracranial bleeding
- •Major surgery or trauma within 10 days
- •Head injury requiring hospitalization within 1 year
- •Intracranial tumor
- •Neurosurgery or non-cataract ophthalmologic surgery within 1 month
- •Thrombocytopenia
研究组 & 干预措施
Enoxaparin
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Major Bleeding Complication
时间窗: 30 Days
Major bleeding complication as defined as spinal, retroperitoneal, or intracranial bleeding; drop in hemoglobin ≥2g/dl or transfusion ≥2U or surgical or medical intervention, death related to bleeding.
Recurrent VTE
时间窗: 30 Days
Major clotting complication (recurrent VTE) as defined as recurrent acute pulmonary embolism confirmed on chest CT or recurrent deep vein thrombosis in the contralateral extremity confirmed with venous ultrasound or CT scan while on once daily enoxaparin therapy.
Death
时间窗: 30 Days
All-cause mortality
次要结局
未报告次要终点
研究者
Samuel Z.Goldhaber, MD
Director, VTE Research Group
Brigham and Women's Hospital