Cerebral VasospasmMilriSpasmNCT03517670
Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm
An observational study of Cerebral Vasospasm and Subarachnoid Hemorrhage, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- What is being tested?
- Rhythmic tolerance, Hematological tolerance and Milrinone efficiency on cerebral vasospasm
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2020to 31 Aug 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Subjects 18 years
- Hospitalized in our intensive care unit
- Subarachnoid hemorrhage proven on CT angiogram
- Cerebral vasospasm proven on CT angiogram
Who cannot join
- Pregnant women
- Minor
- Major under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The aim of this prospective observational study is to evaluate the hemodynamic tolerance of intravenous milrinone for the treatment of arterial vasospasm following subarachnoid hemorrhage. Intravenous milrinone is part of our standard care protocol for the management of cerebral vasospasm in association with nimodipine (intravenous or enteral route) and high arterial blood pressure (mean arterial pressure of 100-120 mmHg, spontaneously or induced by volume expansion and norepinephrine). All patients of our ICU who were diagnosed with cerebral arterial vasospasm during the few days following a subarachnoid hemorrhage will be included.
- Conditions
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- Being tested
- Rhythmic tolerance, Hematological tolerance, Milrinone efficiency on cerebral vasospasm, Milrinone efficiency using the modified Rankin scale
- Keywords
- Cerebral vasospasm, Subarachnoid hemorrhage, Milrinone, Hemodynamic tolerance
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic toleranceOther
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 toleranceOther
Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia
Milrinone efficiency on cerebral vasospasmOther
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 scaleOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 6 months.
Secondary outcomes (4)
Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of
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 Safety Issue: No
Measured: 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 considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia Safety Issue: No
Measured: Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment.
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).
Safety Issue: No
Measured: 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
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.
Safety Issue: No
Measured: At 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start31 Aug 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral VasospasmStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien CADIET, PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517670
- Sponsor's protocol ID
- RC17_0451
- Acronym
- MilriSpasm
- Status last verified
- Mar 2022
- First submitted
- 23 Apr 2018
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm
- ClinicalTrials.gov ID
- NCT03517670
- Acronym / sponsor ID
- MilriSpasm / RC17_0451
- Conditions
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- Keywords
- Cerebral vasospasm, Subarachnoid hemorrhage, Milrinone, Hemodynamic tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 7 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this prospective observational study is to evaluate the hemodynamic tolerance of intravenous milrinone for the treatment of arterial vasospasm following subarachnoid hemorrhage. Intravenous milrinone is part of our standard care protocol for the management of cerebral vasospasm in association with nimodipine (intravenous or enteral route) and high arterial blood pressure (mean arterial pressure of 100-120 mmHg, spontaneously or induced by volume expansion and norepinephrine). All patients of our ICU who were diagnosed with cerebral arterial vasospasm during the few days following a subarachnoid hemorrhage will be included.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Subjects 18 years
- Hospitalized in our intensive care unit
- Subarachnoid hemorrhage proven on CT angiogram
- Cerebral vasospasm proven on CT angiogram
Key exclusion criteria (3 listed)
- Pregnant women
- Minor
- Major under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhythmic toleranceRhythmic 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 toleranceHematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia | Other | – |
| Milrinone efficiency on cerebral vasospasmIt 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 scaleScored 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. | Other | – |
Primary outcome
Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120
Time frame: At 6 months.
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
4 secondary outcomes
Rhythmic tolerance: defined by the occurrence of arrhythmia prompting the initiation of
Time frame: 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
Time frame: Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment.
Milrinone efficiency on cerebral vasospasm
Time frame: 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
Time frame: At 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien CADIET, PH principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Vasospasm and Subarachnoid Hemorrhage, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic tolerance during treatment: defined by a stable mean blood pressure of 100-120 (time frame: At 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.