NCT00170378已完成4 期
The Use of Low Molecular Weight Heparin in Traumatic Brain Injury
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.
研究概览
简要总结
To study the safety and efficacy of early administration of Low Molecular Weight Heparin to patients with traumatic brain injury.
详细描述
Venous thromboembolic (VTE) prophylaxis in trauma patients is a critical clinical problem. Patients with traumatic brain injury usually have effective VTE prophylaxis withheld secondary to concerns of exacerbating intracranial hemorrhage. This study examines the safety and efficacy of early administration (within 24 hrs of admission) of low molecular weight heparin to this patient population with very high VTE risk.
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
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
- •Blunt traumatic brain injury (Marshall II-V)
- •Stable 6 hr. head CT
- •Stable hemoglobin
排除标准
- •Premorbid coagulopathy
- •Pregnancy
- •< 18 y.o.
- •Need for therapeutic anticoagulation
- •Heparin allergy
结局指标
主要结局
Safety: Assess if early administration of LMWH exacerbates intracranial hemorrhage.
次要结局
- Efficacy: Demonstrate effectiveness of dosing regimen in preventing VTE.
研究者
研究点 (2)
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