Evaluation of Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage From a Cerebral Aneurysm
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cerebral Vasospasm
研究概览
简要总结
The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.
详细描述
This is a pilot single center, open-labeled study. Patients with subarachnoid hemorrhage admitted to the hospital and who meet entry criteria will be offered enrollment into the study. The patients will be enrolled promptly after detection of the presence of cerebral vasospasm. Subjects will receive sodium nitrite infusion.
One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Informed consent obtained from a patient or legal representative before enrollment;
- •Admission to hospital following subarachnoid hemorrhage;
- •Aneurysm confirmed by digital subtraction angiography or CT-angiography after admission;
- •Development of the clinical symptoms and /or signs of cerebral vasospasm and CT-angiography results warranting cerebral angiography.
排除标准
- •Rupture of a fusiform, traumatic, or mycotic aneurysm;
- •Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding;
- •Methemoglobin > 2%
- •History of sickle cell disease, thalassemia, or other hemoglobinopathy;
- •Anemia with hemoglobin level less than 6 g/dL;
- •Significant acute or chronic concomitant diseases (including renal, hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 6 months;
- •History of allergy to nitrites or allergy to other substances that could interfere with nitrite metabolism, within 30 days before screening;
- •History of red blood cell glucose-6-phosphate dehydrogenase (G6PD)deficiency;
- •Treatment with allopurinol, a medication that could interfere with nitrite metabolism, within 30 days before screening;
- •Other investigational drug within the past 30 days;
- •other cerebral injury within the past 30 days including previous subarachnoid hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.
研究组 & 干预措施
Sodium Nitrite
One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).
干预措施: Sodium Nitrite (Drug)
结局指标
主要结局
Cerebral Vasospasm
时间窗: 180 minutes
Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.
次要结局
未报告次要终点