Subarachnoid Hemorrhage Clinical Trial
— MilriSpasmOfficial title:
Safety of Intravenous Milrinone for the Treatment of Subarachnoid Hemorrhage-induced Vasospasm
NCT number | NCT03517670 |
Other study ID # | RC17_0451 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 31, 2020 |
Est. completion date | August 31, 2020 |
Verified date | March 2022 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects 18 years - Hospitalized in our intensive care unit - Subarachnoid hemorrhage proven on CT angiogram - Cerebral vasospasm proven on CT angiogram Exclusion Criteria: - Pregnant women - Minor - Major under guardianship |
Country | Name | City | State |
---|---|---|---|
France | CHU Nantes | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 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). | |
Secondary | 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 | Hematological tolerance will be assessed daily through measuring platelet count for the duration of treatment. | |
Secondary | 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 |
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. | |
Secondary | 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 |
At 6 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Recruiting |
NCT04189471 -
Recovery After Cerebral Hemorrhage
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05131295 -
Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
|
Phase 3 | |
Recruiting |
NCT02962349 -
TRansfusion Strategies in Acute Brain INjured Patients
|
N/A | |
Completed |
NCT02872857 -
Subarachnoid Hemorrhage Recovery And Galantamine
|
Phase 1/Phase 2 | |
Completed |
NCT03164434 -
Influence of Drainage on EVD ICP-signal
|
||
Terminated |
NCT02216513 -
Deferoxamine to Prevent Delayed Cerebral Ischemia After Subarachnoid Hemorrhage
|
Phase 0 | |
Not yet recruiting |
NCT00905931 -
Lycopene Following Aneurysmal Subarachnoid Haemorrhage
|
Phase 2 | |
Completed |
NCT01077206 -
High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage
|
Phase 2/Phase 3 | |
Completed |
NCT02389634 -
Identification of Novel Molecular Markers for Vasospasm
|
||
Completed |
NCT00962546 -
Computed Tomographic (CT) Perfusion and CT Angiography as Screening Tools for Vasospasm Following Subarachnoid Hemorrhage
|
N/A | |
Completed |
NCT01261091 -
Early Tracheostomy in Ventilated Stroke Patients
|
N/A | |
Completed |
NCT00507104 -
Pituitary Functions After Traumatic Brain Injury (TBI) and/or Subarachnoid Hemorrhage (SAH)
|
||
Completed |
NCT00071565 -
Familial Intracranial Aneurysm Study II
|
N/A | |
Recruiting |
NCT05113381 -
The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of IVH
|
N/A | |
Completed |
NCT04052646 -
Prehospital Deaths From Spontaneous Subarachnoid Haemorrhages
|
||
Recruiting |
NCT04548596 -
NOninVasive Intracranial prEssure From Transcranial doppLer Ultrasound Development of a Comprehensive Database of Multimodality Monitoring Signals for Brain-Injured Patients
|
||
Recruiting |
NCT06033378 -
Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.
|
N/A | |
Completed |
NCT04308577 -
Diet Induced Ketosis for Brain Injury - A Feasibility Study
|
N/A |