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

Indiana University

Status and phase: Terminated; Phase 2

Conditions: Cerebral Vasospasm

Treatments: Drug: Milrinone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02712788

1505714749

Details and patient eligibility

About

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

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

4 participants in 2 patient groups, including a placebo group

Milrinone

Active Comparator group

Description:

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.

Treatment:

Drug: Milrinone

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo