Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Composite Primary Outcome
研究概览
简要总结
This study will evaluate the hypothesis that the administration of intraventricular tPA reduces the rates of cerebral vasospasm and ventriculoperitoneal shunt-dependent hydrocephalus in patients with aneurysmal subarachnoid hemorrhage.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age greater than 18 years old.
- •SAH due to aneurysm, as determined by CT angiogram or cerebral angiogram.
- •Modified Fisher (mF) grade 3 or 4 SAH, defined as thick cisternal blood without (grade 3) or with (grade 4) intraventrciular blood.
- •Exclusion of the aneurysm from the parent circulation by endovascular embolization (Raymond class I or II) within 48 hours of ictus.
- •Ventriculostomy placement must occur prior to randomization.
- •Informed consent obtained from the patient or patient's decision maker
排除标准
- •Determination by treating physician(s) that no ventriculostomy is needed.
- •Presence of intrinsic clotting disorders (e.g. due to hepatic failure, nephrotic syndrome, etc). Subjects whose pharmacologic anticoagulation is reversed, as determined by PT/INR, PTT within our institution's normal range, will be permitted to participate in this study.
- •Presence of significant anemia, defined as hemoglobin < 8 gm/dL.
- •Patients who undergo endovascular techniques requiring post-operative dual anti-platelet therapy.
- •Residual aneurysm sac filling (Raymond class III occlusion).
- •Aneurysm or vessel perforation during the endovascular procedure.
- •Presence of craniectomy.
- •Significant neurologic disability prior to the onset of SAH.
- •Determination that administration of tPA/placebo cannot be initiated within 72 hours of symptom onset.
- •Presence of untreated intracranial aneurysms larger than 3mm on CT angiography or cerebral angiogram.
研究组 & 干预措施
Intraventricular tPA
Tissue Plasminogen Activator (tPA)
Dose: 1 mg Q8 hr x 12 doses, or until blood is cleared from the ventricles and cisterns Adminstration: Intraventricular; via previously placed external ventricular drain
干预措施: Tissue Plasminogen Activator (Drug)
Placebo
Placebo
Dose 1 mL sterile saline
干预措施: Tissue Plasminogen Activator (Drug)
结局指标
主要结局
Composite Primary Outcome
时间窗: 1-60 days after SAH
The composite primary outcome will consist of the rates of ventriculoperitoneal shunt (VPS) placement, clinically significant vasospasm, and death. VPS placement serves as surrogate measure of hydrocephalus. These outcomes will be measured during the patient's hospitalization.
次要结局
- Rate of intracranial infection(1-14 after SAH)
- Rate of new intracranial hemorrhage(1-14 days after SAH)
研究者
Stephan Munich
Neurosurgery Resident
Rush University Medical Center