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

NCT03517670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-03-03

No results posted yet for this study

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

Interventions

OTHER

Rhythmic tolerance

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

OTHER

Hematological tolerance

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

OTHER

Milrinone efficiency on cerebral vasospasm

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).

OTHER

Milrinone efficiency using the modified Rankin scale

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.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Julien CADIET, PH · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517670 on ClinicalTrials.gov