Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS) at 6 Months
研究概览
简要总结
The purpose of this study is to evaluate the usefulness of adding Milrinone to the current standard treatment for cerebral vasospasm.
详细描述
The goal of this study is to assess the efficacy of milrinone as an agent to treat cerebral vasospasm by adding it to standard therapy. This will take the form of a randomized, controlled trial in which patients will receive either standard hyperdynamic therapy or hyperdynamic therapy + milrinone. The hypothesis of this study is that good outcomes will be 25% more common in the experimental (milrinone) group than the control (standard therapy) group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects ≥ 18 years of age
- •Aneurysmal subarachnoid hemorrhage, proven on CT angiogram or digital subtraction angiography
- •Aneurysm treated, either by endovascular embolization or surgical clip ligation
- •Evidence of increased velocities on transcranial dopplers (TCDs) and/or radiographic evidence of vasospasm as seen on angiogram
- •Cerebral vasospasm as demonstrated by patient's clinical exam (new focal deficit or change in mental status not attributable to any other cause)
排除标准
- •Recurrent subarachnoid hemorrhage
- •Untreated ruptured aneurysm, for any reason
- •Patients who die prior to treatment for aneurysm
- •Patients who are not able to complete at least 6 months of follow-up
- •Patients who are admitted already in vasospasm (i.e. a delayed admission)
- •Creatinine clearance less than 20 ml/min
- •Women with a positive pregnancy test or who are lactating
- •Other comorbidity which may adversely affect patient outcome, at the discretion of the principal investigator
研究组 & 干预措施
Placebo
Placebo (Normal Saline) will be administered intravenously and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.
干预措施: Placebo (Drug)
Milrinone
Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.
干预措施: Milrinone (Drug)
结局指标
主要结局
Modified Rankin Scale (mRS) at 6 Months
时间窗: 6 months
Reported as number for each subject and then will look statistically to see if there is a difference between the active arm and the placebo arm. The Modified Rankin scale is Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to carry out all usual activities, despite some symptoms, 2 = Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 = Severe disability. Requires constant nursing care and attention, bedridden, incontinent, 6 = Death. Higher scores indicate worse outcome.
次要结局
- mRS at 12 Months(12 months)
研究者
Scott Shapiro
MD, Professor of Neurological Surgery
Indiana University