MIVAR - Milrinone Infusion for VAsospam treatment in subarachnoid hemoRrhage

Phase 3

Not yet recruiting

• Conditions: aneurysmal subarachnoid hemorrhage with a vasospasm

• Registration Number: 2024-515994-83-00
• Lead Sponsor: Centre Hospitalier Universitaire D'Angers

Brief Summary

The main objective is to evaluate the efficacy of Milrinone intravenous infusion compare

to placebo to improve the neurological outcome at 3 months in patients with vasospasm

following an aneurysmal SAH.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-08-19
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 370

Inclusion Criteria

Adult patients hospitalized for aneurysmal subarachnoid hemorrhage

Diagnosis of vasospasm confirmed on cerebral angiographic CT-scanner

Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤ 6 hours

Patients consent or patient’s relative (or emergency procedure)

Exclusion Criteria

Initial Glasgow score = 3 with bilaterally mydriasis

Non-affiliation to French health care coverage

Pregnant, nursing or parturient woman

Adult patient deprived of liberty by legal or administrative decision

Adult patient with psychiatric care under duress

Adult patient protected under the law (guardianship)

Inclusion in an other interventional study modifying usual vasospasm management

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 according to medical judgement)

Cardiac failure needing ionotropic administration when randomization has to be performed

Not controlled Intracranial Hypertension when randomization has to be performed

(ICP > 25 mmHg during at least 20 min)

Flutter patient or with cardiac aryhtmiaby atrial fibrillation poorly tolerated

Major hydroelectric problems (hypokaliémia <3 mmol/L)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main primary end point is proportion of patients with a good outcome at 3 months(defined as a modified Rankin (mRS) score ≤2)		The main primary end point is proportion of patients with a good outcome at 3 months(defined as a modified Rankin (mRS) score ≤2)

Secondary Outcome Measures

Name	Time	Method
mortality in intensive care unit, in hospital, at 3 months and 6 months after aneurysm rupture		mortality in intensive care unit, in hospital, at 3 months and 6 months after aneurysm rupture
long term clinical outcomes with modified Rankin score at 6 months and Glasgow Outcome scale Extended (GOS-E) score at 3 and 6 months		long term clinical outcomes with modified Rankin score at 6 months and Glasgow Outcome scale Extended (GOS-E) score at 3 and 6 months
the long term quality of life with EQ-5D at baseline, 3 and 6 months		the long term quality of life with EQ-5D at baseline, 3 and 6 months
effectiveness of the treatment on radiologic term  Angiographic success at D7 and D14 according to angiographic CTscanner with blind radiologist’s analysis (coted as follows: No success, light success, moderate success or important success),  The volume of infarcted areas measured using the control MRI, done between 1 and 3 months after aneurysm rupture.		effectiveness of the treatment on radiologic term  Angiographic success at D7 and D14 according to angiographic CTscanner with blind radiologist’s analysis (coted as follows: No success, light success, moderate success or important success),  The volume of infarcted areas measured using the control MRI, done between 1 and 3 months after aneurysm rupture.
To describe flow velocity variations in middle cerebral artery due to treatment		To describe flow velocity variations in middle cerebral artery due to treatment
length of hospitalization in intensive care unit and in hospital (including recovery centers)		length of hospitalization in intensive care unit and in hospital (including recovery centers)
To evaluate the length of hospitalization in intensive care unit and in hospital (including recovery centers)		To evaluate the length of hospitalization in intensive care unit and in hospital (including recovery centers)
hemodynamic tolerance :need to introduce and/or increase doses of catecholamines by + 50% during the first 24 hours (% of patients and mean doses of treatment)		hemodynamic tolerance :need to introduce and/or increase doses of catecholamines by + 50% during the first 24 hours (% of patients and mean doses of treatment)
metabolic tolerance : The occurrence of dysnatremia (<135 mmol / L or> 155 mmol / L), Daily diuresis.		metabolic tolerance : The occurrence of dysnatremia (<135 mmol / L or> 155 mmol / L), Daily diuresis.

Trial Locations

Locations (15)

Centre Hospitalier Universitaire De Bordeaux; 🇫🇷 Bordeaux, France

Centre Hospitalier Regional Et Universitaire De Brest; 🇫🇷 Brest, France

University Hospital Of Clermont-Ferrand; 🇫🇷 Clermont Ferrand Cedex 1, France

Centre Hospitalier Universitaire De Caen Normandie; 🇫🇷 Caen Cedex 9, France

Fondation A De Rothschild; 🇫🇷 Paris, France

CHU Besancon; 🇫🇷 Besancon Cedex, France

Centre Hospitalier Regional Universitaire De Tours; 🇫🇷 Tours Cedex 9, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris, France

Centre Hospitalier Universitaire De Lille; 🇫🇷 Lille Cedex, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes, France

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Centre Hospitalier Universitaire De Bordeaux

🇫🇷Bordeaux, France

Hugues De Courson

Site contact

+33557821019

hugues.de-courson@chu-bordeaux.fr