Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm

NCT03517670 | Completed

• 1 other identifier: RC17_0451
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the tolerance of intravenous milrinone combined to the current standard treatment for cerebral vasospasm following subarachnoid hemorrhage. Assessment of IV milrinone safety in this setting is mandatory before the conduction of a large study assessing its effectiveness.

Conditions

Cerebral Vasospasm; Subarachnoid Hemorrhage

Keywords

Cerebral vasospasm; Subarachnoid hemorrhage; Milrinone; Hemodynamic tolerance

Outcome Measures

Primary Outcomes (1)

• Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120

  A good hemodynamic tolerance is defined by a stable mean blood pressure of 100-120 mmHg without neither the need to decrease milrinone infusion rate below 0.5 g.kg-1.min-1 nor the need to increase norepinephrine above 1g.kg-1.min-1 Safety Issue: No

  At 6 months.

Secondary Outcomes (4)

• Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of

  Rhythmic tolerance will be assessed for the duration of treatment, which will be on average one month.Heart rate and rhythm will be measured continuously, but assessed for fluctuation outside the reference range daily (during the length of treatment).

• Hematological tolerance: will be considered good if milrinone infusion was not interrupted

  Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment.

• Milrinone efficiency on cerebral vasospasm

  Milrinone efficiency on cerebral vasospasm will be assessed for the duration of treatment, which will be on average one month. Mean velocity and the lindegard index will be initially measured at 0, 2, 12 and 24 hours; and subsequently daily.

• Milrinone efficiency on patient-centered neurological outcome using the modified Rankin scale

  At 6 months.

Interventions

Rhythmic tolerance OTHER

Rhythmic intolerance is defined by the occurrence of arrhythmia prompting the initiation of an antiarrhythmic medication and the need to decrease or even to stop the infusion of milrinone

Hematological tolerance OTHER

Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia

Milrinone efficiency on cerebral vasospasm OTHER

It will be assessed using ultrasound measurements of middle cerebral arteries velocities. A decrease of at least 20% of the mean velocity or of the Lindegaard index will be considered as a significant positive effect of the treatment (including milrinone).

Milrinone efficiency using the modified Rankin scale OTHER

Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to perform all usual activities, despite certain symptoms, 2= Slight disability. Able to take care of his own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderate severe disability. Unable to meet their own physical needs without help and unable to walk without help, 5 Severe disability. Needs constant care and attention, bedridden, incontinent, 6 = Death.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Purpose: Treatment Study Phase: NA Intervention Model: Single group Number of Arms: 1 Masking: Open label Allocation: NA Study Endpoint Classification: Safety Enrollment: 60 participants

You may qualify if:

• Subjects 18 years
• Hospitalized in our intensive care unit
• Subarachnoid hemorrhage proven on CT angiogram
• Cerebral vasospasm proven on CT angiogram

You may not qualify if:

• Pregnant women
• Minor
• Major under guardianship

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien CADIET, PH

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 7, 2018
• Study Start: August 31, 2020
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 3, 2022

Record last verified: 2022-03

Locations

FR (1)