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Cerebral hemodynamic optimization by milrinone for the prevention of delayed cerebral ischemia in severe subarachnoid hemorrhage -OPTIMIL Study-

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513410-35-00
Acronym
RC31/18/0472
Enrollment
100
Registered
2024-09-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

aneurysmal subarachnoid hemorrhage

Brief summary

The primary outcome is the volume of DCI lesions measured on a CT scan at 1 month

Detailed description

→ Radiological parameters on CT at 1 month: -percentage of patients with DCI, → Evolution in intensive care: •Neurological complications: -number of episodes of PtiO2 below the ischemic threshold in intensive care: PtiO2 <20 mmHg (moderate hypoxia) and <15mmHg (severe hypoxia) for at least 15 minutes; - total duration of episodes of PtiO2 <20mmHg (moderate hypoxia) and <15mmHg (severe hypoxia) -number of recourse to an endovascular treatment -intracranial hypertension in intensive care: ICP> 20 mmHg for at least 15 minutes., Evolution in intensive care: • Number and type of non-neurological complications, → Evolution in intensive care: • Variation in general and cerebral hemodynamics (HR, MAP, ICP, CPP, transcranial Doppler velocity) with transthoracic cardiac ultrasound (TTE) cardiac output or pulse-wave contour study with transpulmonary thermodilution (PICCO) ®), → Evolution in intensive care: • Number of days in intensive care, → Evolution in intensive care: • Number of days with mechanical ventilation, → Prognosis: - neurological prognosis at 1 month, 3 months, 6 months and 1 year evaluated by the modified Rankin score (good prognosis: mRS 0, 1 and 2 / poor prognosis: mRS 3, 4 and 5) and the Glasgow Outcome Scale extended (good outcome: GOSE 5 to 8 / poor outcome: GOSE 1 to 4).- Sickness Impact Profile (SIP-65) quality-oflife scale at 3 months, 6 months and 1 year. - Mortality at 1 month, 3 months, 6 months and 1 year - number of days of hospitalization, → Number of adverse events, → Build up a biocollection for the evaluation of plasma brain biomarkers or other potential biomarkers

Interventions

DRUGMILRINONE
DRUGsolution pour perfusion

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary outcome is the volume of DCI lesions measured on a CT scan at 1 month

Secondary

MeasureTime frame
→ Radiological parameters on CT at 1 month: -percentage of patients with DCI, → Evolution in intensive care: •Neurological complications: -number of episodes of PtiO2 below the ischemic threshold in intensive care: PtiO2 <20 mmHg (moderate hypoxia) and <15mmHg (severe hypoxia) for at least 15 minutes; - total duration of episodes of PtiO2 <20mmHg (moderate hypoxia) and <15mmHg (severe hypoxia) -number of recourse to an endovascular treatment -intracranial hypertension in intensive care: ICP> 20 mmHg for at least 15 minutes., Evolution in intensive care: • Number and type of non-neurological complications, → Evolution in intensive care: • Variation in general and cerebral hemodynamics (HR, MAP, ICP, CPP, transcranial Doppler velocity) with transthoracic cardiac ultrasound (TTE) cardiac output or pulse-wave contour study with transpulmonary thermodilution (PICCO) ®), → Evolution in intensive care: • Number of days in intensive care, → Evolution in intensive care: • Number of days with me

Countries

France

Outcome results

None listed

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