Double-Blind, Placebo-Controlled, Pilot Study, In Medical Patients With Prophylaxis Of Venous Thromboembolism in Primary Care
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.
研究概览
简要总结
The primary objective was to study the clinical benefit with dalteparin sodium in thromboprophylaxis in primary care medical subjects. The secondary objective was a pharmacoeconomic evaluation of hromboprophylaxis with dalteparin sodium in primary care medical subjects.
详细描述
The study was prematurely terminated on December 9, 2003. The reason for the early termination was not related to a safety or efficacy issue. It was related to the difficulty in recruiting patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years
- •Confinement to bed for more than 3 days, due to:
- •Heart failure
- •Exacerbated chronic obstructive pulmonary disease
- •Acute rheumatic involvement
- •Written informed consent
排除标准
- •Anticoagulant treatment in the previous 3 months
- •Stroke or major surgery in the previous 3 months
- •Systolic pressure >200 mmHg or diastolic pressure >120 mmHg
- •Known chronic hepatopathy
- •Active hemorrhage in any site in the previous 3 months
- •Active peptic ulcer
- •Bacterial endocarditis
- •Conditions that can increase the risk of hemorrhage
- •Known coagulation disorders
- •Hypersensitivity to heparin or HIT
- •Life expectancy of less than 3 months
- •Previous confinement to bed during more than 3 days
研究组 & 干预措施
Dalteparin sodium
干预措施: Dalteparin sodium (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of the endpoint made up of objectively demonstrated deep vein thrombosis (DVT), pulmonary embolism (PE) diagnosed by objective tests or death at the end of the follow-up period, 1 month after the end of the bedridden period.
时间窗: 1 month
次要结局
- Incidence of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE) and tolerability at the end of the follow-up period.(1 month)