Actively Recruiting
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Led by University Hospital, Toulouse · Updated on 2024-09-25
234
Participants Needed
5
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to evaluate, in comatose patients and / or sedated on D3 following a severe SAHa (WFNS IV -V), the effect of 10 days of milrinone versus placebo, in addition to the usual management, on the volume of DCI lesions measured on CT scan at 1 month.
CONDITIONS
Official Title
Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with severe aneurysmal subarachnoid hemorrhage (WFNS IV or V) who are comatose or require sedation on day 3
- No pre-existing neurological disability (modified Rankin Scale 0-2)
- Age 18 years or older
- Affiliated with social security or covered through a third party
- Not under tutorship, curatorship, or judicial protection
- Signed informed consent obtained from a relative or trusted person after clear information
You will not qualify if you...
- Patients with non-severe aneurysmal subarachnoid hemorrhage (WFNS I, II, or III)
- Major hemorrhagic or ischemic complication during aneurysm treatment threatening short-term survival
- Heart failure requiring inotropic drugs at randomization
- Intracranial hypertension (ICP > 25 mmHg for at least 20 minutes) at randomization
- Severe obstructive heart diseases
- Atrial flutter or atrial fibrillation
- Hypotension or severe hypovolemia causing unstable blood pressure
- Septic shock
- Acute or chronic kidney failure with creatinine clearance under 50 ml/min
- Major electrolyte imbalances such as potassium below 3 mmol/L
- Known allergy to milrinone or its components
- Early limitation of life-supportive care
- Pregnancy or breastfeeding
- Permanent contraindications to MRI
- Participation in another clinical interventional trial
AI-Screening
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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
CONTACT
N
Nadera AINAOUI
CONTACT
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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