Study Effects of Ultra-slow Continuous Intravenous Infusion of Unfractionated Heparin on Progressive Cerebral Infarction - a Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- change of NIHSS at 4 weeks
研究概览
简要总结
A clinical trial to study the effects of dosage, infusion methods and complications of unfractionated heparin (UFH) treating acute progressive cerebral infraction was conducted. In this study, we observed the effects of four UFH treatments on 480 acute progressive cerebral infraction patients during from the 6th and the 72nd hour after the attack. It was concluded that the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction, increase the cure rate, decrease the recurrence rate, and improve long-term quality of daily life. It is more effective than the treatment of intravenous infusion of low- molecular- weight UFH at once a day, and the risk of bleeding may not necessarily be increased.
详细描述
Treatment' effectiveness rates of the four groups were 95.80%, 85.22%, 85.47%, and 87.72% respectively. The result of Group A was significantly different from those of Group B, C, and D (p <0.05). The adverse complication occurrence rates of the four groups were 5.88%, 3.48%, 4.27% and 3.51%.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Time after breakout: 6- 72 hours
- •Blood pressure: below 180/100 mm Hg (1 mm Hg= 0.133 kPa)
- •Paralyzed limb muscle strength: Level 0
- •Being conscious or in mild or moderate coma, and hernia- free
- •The nerve function continued to aggravate from several hours to a week after the breakout.
- •No abnormal blood coagulation Platelet count Plt >10×109/L
- •Brain CT or MRI confirming and ruling out the occurrence of bleeding
- •Match the diagnostic standards of acute cerebral infraction established by the 4th Chinese China Neurology Association
- •Informed consent Agreement Signed
排除标准
- •History of intracranial hemorrhage bleeding risk or Plt <10 × 109/ L
- •Record of severe heart, liver, or renal insufficiency or severe diabetes mellitus
- •Infarct area larger than 1/3 of hemispheric area
结局指标
主要结局
change of NIHSS at 4 weeks
时间窗: 4 weeks
the ultra-slow continuous intravenous infusion of UFH can significantly reduce the neurological deficit score of patients with progressive cerebral infarction,
次要结局
- the recurrence rate at 6 months(6 months)
- changs of ADL after 6 months(6 months)
- Number of patients with Adverse Events(4 weeks)