Actively Recruiting
Efficacy of 10 Days Intravenous Milrinone to Optimize Brain Blood Flow and Prevent Delayed Cerebral Ischemia in Severe Subarachnoid Hemorrhage
Led by University Hospital, Toulouse · Updated on 2024-09-25
234
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the effect of intravenous milrinone on brain blood flow and prevention of delayed cerebral ischemia (DCI) in adults with severe subarachnoid hemorrhage caused by ruptured brain aneurysms. The study focuses on patients who are comatose or sedated shortly after the hemorrhage and aims to determine how 10 days of milrinone compared to placebo affects the volume of brain lesions related to DCI. This randomized, double-blind, multi-center trial addresses a major cause of death and disability where current treatments lack strong scientific evidence. Participants receive either standard care plus milrinone infusion or standard care plus a placebo infusion starting from day 4 to day 14 after aneurysm treatment. Milrinone is given intravenously at a dose of 0.75 micrograms per kilogram per minute. Both groups are closely monitored for signs of vasospasm and may receive additional endovascular treatment if needed. Daily clinical exams and collection of biological data occur during this high-risk period. The study observes complications related to intensive care such as neurological, pulmonary, cardiac, and septic events. Throughout the study, brain CT scans are done at 48 hours post-treatment and again at 1 month to measure DCI lesion volumes. Neurological outcomes, quality of life, and mortality are assessed at multiple points up to one year. Safety is monitored continuously, and detailed data on complications and time spent in intensive care are recorded. This comprehensive follow-up helps researchers evaluate the impact of milrinone on brain injury and recovery after severe subarachnoid hemorrhage.
CONDITIONS
Brief Title
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Severe subarachnoid hemorrhage (WFNS IV or V) with coma or sedation on day 3
- No pre-existing neurological disability (modified Rankin score 0-2)
- Affiliated with social security or equivalent
- Not under legal guardianship or judicial protection
- Signed informed consent obtained from a relative or trusted person after clear information
You will not qualify if you...
- Non-severe subarachnoid hemorrhage (WFNS I, II, III)
- Major complications during aneurysm treatment threatening short-term survival
- Heart failure needing inotropic drugs at randomization
- Intracranial hypertension (ICP >25 mmHg for at least 20 minutes) at randomization
- Severe obstructive heart disease
- Atrial flutter or atrial fibrillation
- Hemodynamic instability due to hypotension or severe low blood volume
- Septic shock
- Acute or chronic kidney failure (creatinine clearance <50 ml/min)
- Major electrolyte disturbances (potassium <3 mmol/L)
- Known allergy to milrinone or its ingredients
- Early limitation of life-sustaining care
- Pregnancy or breastfeeding
- Permanent contraindications to MRI
- Participation in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 11 days
Participants receive intravenous milrinone or placebo from Day 4 to Day 14 after aneurysm treatment, along with standard care. Clinical examinations and biological data are collected daily during this period. Occurrence of vasospasm is closely monitored and endovascular treatment may be provided if needed.
Daily visits from Day 4 to Day 14
Duration - 1 year
Participants undergo CT scans and assessments of neurological prognosis, quality of life, and mortality at 1 month, 3 months, 6 months, and 1 year after treatment. Adverse events and complications are monitored throughout this period.
Visits at 1 month, 3 months, 6 months, and 1 year
Trial Site Locations
Total: 5 locations
1
University Hospital Bordeaux
Bordeaux, France
Active, Not Recruiting
2
CHUGA
Grenoble, France
Active, Not Recruiting
3
University Hospital of La Réunion
La Réunion, France
Actively Recruiting
4
HCL
Lyon, France
Actively Recruiting
5
University Hospital of Toulouse
Toulouse, France
Actively Recruiting
Research Team
T
Thomas Geeraerts, MD PhD
N
Nadera AINAOUI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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