NCT02323685已完成2 期
Single Escalating-dose, Open-label Study to Assess the Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) After Acute Aneurysmal Subarachnoid Hemorrhage (SAH)
Prolong Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
研究概览
简要总结
Safety and effect of SANGUINATE on patients DCI following SAH.
详细描述
The purpose of this study is to study the safety and effect of SANGUINATE on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated written informed consent by the subject or his/her legally authorized representative;
- •Modified Rankin (mRankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage;
- •Ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the Procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and
- •Hunt and Hess (H&H) grade 3 or 4, or World Federation of Neurological Surgeons (WFNS) score 3 or 4 prior to the Procedure, and Modified Fisher (mFisher) grade 3 or 4, prior to the Procedure; or
- •Clinical signs of ("symptomatic") delayed cerebral ischemia; or
- •Angiographic evidence of cerebral vasospasm
排除标准
- •In the judgment of the Investigator the patient is not a good candidate for the study
- •Evidence of rebleed following the Procedure
- •Subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation
- •Diagnosed moderate to severe pulmonary hypertension
- •Radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of Kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion)
- •History within the past 6 months and/or finding of decompensated heart failure
- •Acute myocardial infarction within 3 months prior to the administration of the study drug
- •Left ventricular ejection fraction <40%, as determined by prior echocardiography or clinical signs of CHF
- •Medical history or concurrent evidence of moderate to severe renal insufficiency (estimated creatinine clearance < 30 mL/min)
结局指标
主要结局
Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
时间窗: Up to 30 days
Safety assessments to include vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET)
时间窗: Up to 30 days
Blood oxygenation and blood flow will be assessed using Postitron Emission Tomography (PET)
次要结局
- Changes in Blood Gases as measured by Hemoximetry(Up to 30 days)
- Incidence, location, and size of cerebral infarction as measured by MRI(Up to 30 days)
- Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)(Up to 30 days)
研究者
研究点 (2)
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