Skip to content

MIVAR - Milrinone Infusion for VAsospam treatment in subarachnoid hemoRrhage

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515994-83-00
Acronym
49RC19_0016
Enrollment
370
Registered
2024-08-19
Start date
2026-01-13
Completion date
2026-01-13
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aneurysmal subarachnoid hemorrhage with a vasospasm

Brief summary

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

Detailed description

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, 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., 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), 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), metabolic tolerance : The occurrence of dysnatremia (<135 mmol / L or> 155 mmol / L), Daily diuresis.

Interventions

DRUGMILRINONE STRAGEN 1mg/ml
DRUGsolution injectable

Sponsors

Centre Hospitalier Universitaire D'Angers
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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, 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., 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), To evaluate the length of hospitalization in intensive care unit and in hospital (including recovery centers), hemodynamic tolerance :need to introduce and/or in

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026