Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Status: | Terminated |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/5/2018 |
Start Date: | April 18, 2016 |
End Date: | May 3, 2018 |
The purpose of this study is to evaluate the usefulness of adding Milrinone to the current
standard treatment for cerebral vasospasm.
standard treatment for cerebral vasospasm.
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.
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
We found this trial at
1
site
Indianapolis, Indiana 46202
Principal Investigator: Scott Shapiro, MD
Phone: 317-396-1300
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