Relationships Among FVIII, t-PA/PAI-1, and MMP-9 Levels and Intracranial Hemorrhage Complications After Thrombolysis With Alteplase in Patients With Acute Ischemic Stroke: Protocol for a Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Intracranial hemorrhage
研究概览
简要总结
The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis.
详细描述
Patients with acute ischemic stroke treated with alteplase within 4.5 hours after the onset of stroke symptoms will be recruited in this study. All participants will be divided into two groups according to whether intracranial hemorrhage occurred within 3 days after treatment with alteplase for analysis. Differences in FVIII, t-PA/PAI-1, and MMP-9 levels before and after thrombolytic therapy will be examined in both groups. This study will be conducted at Zhujiang Hospital of Southern Medical University, Nanfang Hospital of Southern Medical University, and the First Affiliated Hospital of Jinan University.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ischemic stroke and within the time window of thrombolysis (Onset of symptoms no more than 4.5 hours )
- •18 y age 85 y•
- •Symptoms of neurological deficits caused by cerebral infarction
- •Informed consent form to confirm thrombolytic therapy have signed by patients or their family.
排除标准
- •A history of major head trauma or stroke in the past 3 months
- •Suspicious subarachnoid hemorrhage
- •Arterial puncture at noncompressible site in the last week
- •History of intracranial hemorrhage
- •Intracranial neoplasm, arteriovenous malformation, or aneurysm
- •Recent intracranial or intraspinal surgery
- •Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)
- •Active internal bleeding or Acute bleeding diathesis
- •Platelet count <100×109·L-1
- •Heparin received within 48 h resulting in aPTT above the upper limit of normal
- •Current use of anticoagulant with INR >1.7 or PT >15 s
- •Current use of thrombin inhibitors or factor Xa inhibitors
- •Abnormal laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
- •Blood glucose concentration > 2.7 mmol/L
- •CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)
- •Mild cerebral infarction or rapid improvement of symptoms of cerebral infarction
- •Symptoms of neurological impairment after seizures
- •Major surgery or severe trauma in the past 2 weeks
- •Gastrointestinal or urinary bleeding in the past 3 weeks
- •History of myocardial infarction in the past 3 months
- •Combine diseases that may affect outcomes,such as Anemia, hemophilia
- •History of autoimmune disease or organ transplantation
- •Pregnancy or breastfeeding women
研究组 & 干预措施
experimental group
The patients who were treated with Ateptidase had intracranial haemorrhage adverse reactions
干预措施: Ateptidase (Drug)
control group
The patients who were treated with Ateptidase did not have intracranial haemorrhage adverse reactions.
干预措施: Ateptidase (Drug)
结局指标
主要结局
Intracranial hemorrhage
时间窗: 3 days
The occurrence of intracranial haemorrhage adverse reactions in ischemic stroke patients receiving thrombolytic therapy by alteplase
次要结局
未报告次要终点