Status:
RECRUITING
Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage
Lead Sponsor:
University Hospital, Angers
Conditions:
Vasospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm...
Detailed Description
Subarachnoid hemorrhage (SAH) is relatively frequent, accounting for 5% of strokes, and affects a relatively young population. It is essentially caused by cerebral aneurysm rupture. Mortality can reac...
Eligibility Criteria
Inclusion
- Adult patients hospitalized for aneurysmal SAH
- First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner
- Delay between diagnosis of vasospasm (done by CT-scanner) and inclusion ≤6 hours
- Informed consent from a legal representative, or emergency procedure
Exclusion
- Initial Glasgow score at 3 with a bilateral mydriasis
- Moribund patient
- Contraindication to Milrinone (notably obstructive cardiomyopathy…)
- Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment in this case according to medical judgement)
- Cardiac failure requiring inotrope administration at the time of randomisation
- Uncontrolled elevated intra-cranial pressure (i.e. ICP\>25 mmHg for more than 20 minutes)
- Patient with flutter or cardiac arrhythmia (atrial fibrillation) poorly tolerated
- Major metabolic disturbance (uncorrected hypokalaemia \<3 mmol/L)
- Non-affiliation to French health care coverage,
- Pregnant, breastfeeding or parturient woman
- Adult deprived of their liberty by judicial or administrative decision
- Adult under compulsory psychiatric care
- Adult patient protected under the law (guardianship or trusteeship)
- Inclusion in an interventional study using Milrinone, or evaluating a treatment of cerebral vasospasm or with the same primary endpoint (mRS at 3 months).
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 11 2026
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04362527
Start Date
August 10 2020
End Date
January 11 2026
Last Update
September 19 2025
Active Locations (16)
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1
CHU Angers
Angers, France
2
CHU Besançon
Besançon, France
3
CHU Bordeaux
Bordeaux, France
4
CHU Brest
Brest, France