Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- mRS score in 90 days
研究概览
简要总结
This research is based on clinic treatment of intravenous thrombolysis for patients with acute ischemic stroke.By building up a database of these patients, the investigators aim to find some significance between groups by analyzing population information, clinical status and such for better evaluation and optimal treatment decision.
详细描述
With the highest incidence rate,the population in northeast of China is severely tormented by stroke, especially ischemic stroke. The investigators lunch this project by building up a database of detailed information of patients that fits the criteria of intravenous thrombolysis therapy.Including biochemical markers,imaging and follow-up,investigators intend to analysis these data,find factors that contributes to better prognosis,so as to push forward the prevention and control work.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of ischemic stroke causing measurable neurological deficit
- •Onset of symptoms <4.5 h before treatment begins
排除标准
- •Significant head trauma or prior stroke in the previous 3 mo
- •Symptoms suggest SAH
- •Arterial puncture at noncompressible site in previous 7 d
- •History of previous intracranial hemorrhage
- •Intracranial neoplasm, AVM, or aneurysm
- •Recent intracranial or intraspinal surgery
- •Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)
- •Active internal bleeding
- •Acute bleeding diathesis, including but not limited to
- •Platelet count <100 000/mm3
- •Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal
- •Current use of anticoagulant with INR >1.7 or PT >15 s
- •Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
- •Blood glucose concentration <50 mg/dL (2.7 mmol/L)
- •CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)
- •Relative exclusion criteria
- •Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present
- •Only minor or rapidly improving stroke symptoms (clearing spontaneously)
- •Seizure at onset with postictal residual neurological impairments
- •Major surgery or serious trauma within previous 14 d
- •Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d)
- •Recent acute myocardial infarction (within previous 3 mo)
结局指标
主要结局
mRS score in 90 days
时间窗: 90 days
Using mRS score to evaluate the effective of thrombolysis among different groups.
Stroke recurrence within 90 days
时间窗: 90 days
Newly onset stroke that the time interval was less than 90 days from the original stroke event was considered as stroke recurrence. Ischemic stroke was defined as acute focal brain or retinal infarction.
次要结局
- Cardiovascular death in 1 year(1 year)
- Post-stroke disability in 1 year(1 year)
研究者
Yi Yang
Associate dean, Director of Cerebrovascular Disease Center
The First Hospital of Jilin University