LITE Study, Appendix A (HOME-LITE), Amendment 6
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
研究概览
简要总结
The purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.
详细描述
Two studies demonstrated that out-of-hospital low-molecular-weight heparin given by twice daily subcutaneous injection without laboratory monitoring was as effective and as safe as continuous intravenous heparin given in-hospital. Innohep (tinzaparin) has been shown to be safe and effective for both the initial and long-term treatment of DVT. The Home LITE study compares long-term Innohep treatment to treatment with a combination of initial low-molecular-weight heparin followed by standard long-term warfarin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 having a first or recurrent episode of acute proximal vein thrombosis who are eligible for outpatient or home care during the initial therapy.
排除标准
- •Any condition which, in the opinion of the investigator, precludes entire out-of-hospital treatment
- •Presence of familial bleeding diathesis or the presence of active bleeding contraindicating anticoagulant therapy
- •Receiving therapeutic heparin for more than 48 hours or have already been on warfarin for more than 2 days for the treatment of proximal deep vein thrombosis
- •Receiving long-term warfarin treatment
- •Females who are pregnant
- •Known allergy to heparin, warfarin sodium, or bisulfites
- •History of heparin-associated thrombocytopenia
- •Severe malignant hypertension
- •Hepatic encephalopathy
- •Severe renal failure
- •Inability to attend follow-up due to geographic inaccessibility
- •Inability or refusal to give signed informed consent
- •Mothers who are breast-feeding and who are unable to refuse to discontinue breast-feeding during study treatment
结局指标
主要结局
objectively documented recurrent venous thromboembolism during initial treatment or during the 12 week follow-up period
death during initial treatment or during the 12 week follow-up period
safety endpoint for assessing harm was the occurrence of bleeding (all, major or minor) during the 12 week treatment interval
次要结局
- recurrent venous thromboembolism at 12 months
- death at 12 months