Cerebral hemodynamic optimization by milrinone for the prevention of delayed cerebral ischemia in severe subarachnoid hemorrhages

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000509-58-FR

Enrollment

234

Registered

2019-08-06

Start date

2019-10-08

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

delayed cerebral ischemia in severe subarachnoid hemorrhages MedDRA version: 20.1 Level: LLT Classification code 10019587 Term: Hemorrhage subarachnoid System Organ Class: 100000004852

Interventions

Trade Name: Milrinone MEDAC 10mg/10 ml, solution injectable Product Name: milrinone Pharmaceutical Form: Solution for injection/infusion Pharmaceutical form of the placebo: Solution for injection/infu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma or need for sedation at D3 - absence of pre-existing neurological handicap (mRS 0-2) - major patient - affiliation to social security or benefiting through a third person - free patient, without tutorship or curatorship or under judicial protection - obtaining a signed informed consent by a relative (or the person of trust) after clear and fair information about the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 234 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 234

Exclusion criteria

Exclusion criteria: - patients with non-severe SAHa (WFNS I, II and III) - Occurrence of a documented ischemic complication during the procedure of aneurysm treatment: transient or permanent arterial occlusion, visualization of a thrombus, and dissection of an axis requiring stenting. - heart failure requiring inotropic administration at the time of randomization - ICHT at the time of randomisation (ICP> 25 mmHg for at least 20 min) - known severe obstructive heart diseases - flutter patient or atrial fibrillation - hypotension and / or severe hypovolemia with hemodynamic instability - septic shock - acute / chronic renal insufficiency (Cl <50ml / min) - major hydroelectrolytic disorders (hypokalemia <3 mmol / L) - known hypersensitivity to milrinone or any of the excipients - pregnancy, breastfeeding - permanent contraindications to MRI

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 MRI at 1 month.;Secondary Objective: Compare the two groups in terms of: ? Radiological parameters on MRI at 1 month: -percentage of patients with DCI ? Evolution in intensive care: •Neurological complications: -number and total duration of episodes of moderate and severe hypoxia -number of recourse to an endovascular treatment -intracranial hypertension in intensive care • Number and type of non-neurological complications • Variation in general and cerebral hemodynamics • Number of days 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 - Sickness Impact Profile (SIP-65) quality-of-life 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 ? Comparison of the manual measurement method of ischemic volume on MRI at 1 month to an automated method ? Number of adverse events ;Primary end point(s): volume of DCI lesions measured on MRI at 1 month;Timepoint(s) of evaluation of this end point: one month	—

Measure

Time frame

Main Objective: 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 MRI at 1 month.;Secondary Objective: Compare the two groups in terms of: ? Radiological parameters on MRI at 1 month: -percentage of patients with DCI ? Evolution in intensive care: •Neurological complications: -number and total duration of episodes of moderate and severe hypoxia -number of recourse to an endovascular treatment -intracranial hypertension in intensive care • Number and type of non-neurological complications • Variation in general and cerebral hemodynamics • Number of days 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 - Sickness Impact Profile (SIP-65) quality-of-life 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 ? Comparison of the manual measurement method of ischemic volume on MRI at 1 month to an automated method ? Number of adverse events ;Primary end point(s): volume of DCI lesions measured on MRI at 1 month;Timepoint(s) of evaluation of this end point: one month

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Secondary

Measure	Time frame
Secondary end point(s): ? Radiological parameters on MRI at 1 month: -percentage of patients with DCI ? Evolution in intensive care: •Neurological complications: -number and total duration of episodes of moderate and severe hypoxia -number of recourse to an endovascular treatment -intracranial hypertension in intensive care • Number and type of non-neurological complications • Variation in general and cerebral hemodynamics • Number of days 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 - Sickness Impact Profile (SIP-65) quality-of-life 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 ? Comparison of the manual measurement method of ischemic volume on MRI at 1 month to an automated method ? Number of adverse events ;Timepoint(s) of evaluation of this end point: -1 month -3 month -6 month -1 year	—

Measure

Time frame

Secondary end point(s): ? Radiological parameters on MRI at 1 month: -percentage of patients with DCI ? Evolution in intensive care: •Neurological complications: -number and total duration of episodes of moderate and severe hypoxia -number of recourse to an endovascular treatment -intracranial hypertension in intensive care • Number and type of non-neurological complications • Variation in general and cerebral hemodynamics • Number of days 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 - Sickness Impact Profile (SIP-65) quality-of-life 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 ? Comparison of the manual measurement method of ischemic volume on MRI at 1 month to an automated method ? Number of adverse events ;Timepoint(s) of evaluation of this end point: -1 month -3 month -6 month -1 year

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Countries

France

Contacts

Public ContactReglementary CRA

CHU de Toulouse

belloc.a@chu-toulouse.fr33561777032

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026