Milrinone in Addition to Hyperdynamic Therapy in the Treatment of Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-18

Study Completion Date

2018-05-03

Brief Summary

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The purpose of this study is to evaluate the usefulness of adding Milrinone to the current standard treatment for cerebral vasospasm.

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Detailed Description

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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.

Conditions

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Cerebral Vasospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Milrinone

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Milrinone

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No