NL-OMON39940尚未招募4 期
Prophylaxis of venous thromboembolism in patients with a fracture of the lower extremity being treated conservatively with a below-knee plaster cast. - PROTECT
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The study groups and the control group will consist of patients of 18 years or older with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks.
排除标准
- •Delay between injury and randomisation greater than three days
- •Pregnancy/lactation
- •Severe hepatic impairment
- •Known hypersensitivity to fraxiparine or fondaparinux
- •History of venous thromboembolism
- •Documented congenital or acquired bleeding tendency/disorder(s)
- •Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis
- •Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
- •Haemorrhagic stroke within the previous two months
- •Intraocular, spinal, and/or brain surgery within the previous twelve months
- •Major surgery within the previous two months
- •Treatment with LMWH or other anticoagulants
- •Inability or refusal to give informed consent
- •Inability to comply with the study-instructions
研究者
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