MILRINONE for Aneurysmal subarachnoid hemorrhage

Inclusion criteria

• {"criterion_text":"- patients with severe SAHa (WFNS IV and V)\n- absence of pre-existing neurological handicap (mRS 0-2)\n- major patient (≥ 18 years)\n- affiliation to social security or benefiting through a third person\n- free patient, without tutorship or curatorship or under judicial protection\n- obtaining a signed informed consent by a relative (or the person of trust) after clear and fair information about the study."}

Exclusion criteria

• {"criterion_text":"- patients with non-severe SAHa (WFNS I, II and III)\n- major hydroelectrolytic disorders (hypokalemia <3 mmol / L)\n- known hypersensitivity to milrinone or any of the excipients\n- Early limitation of life-sustaining care\n- pregnancy, breastfeeding\npermanent contraindications to MRI\n- participation in another clinical interventional pharmacological study that may interfere with the objective of the study\n- Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the short-term vital prognosis\n- heart failure requiring inotropic administration at the time of randomization\n- ICHT at the time of randomisation (ICP> 25 mmHg for at least 20 min)\n- known severe obstructive heart diseases\n- flutter patient or atrial fibrillation\n- hypotension and / or severe hypovolemia with hemodynamic instability\n- septic shock\n- acute / chronic renal insufficiency (Cl <50ml / min)"}

Primary endpoints

• {"endpoint_text":"- The primary outcome is the volume of DCI lesions measured on a CT scan at 1 month","definition_or_measurement_approach":"Volume of delayed cerebral ischemia (DCI) lesions measured on CT scan at 1 month (1 month +/- 4 days) after aneurysm rupture."}

Secondary endpoints

• {"endpoint_text":"- → Radiological parameters on CT at 1 month: -percentage of patients with DCI","definition_or_measurement_approach":"Radiological parameter: percentage of patients with delayed cerebral ischemia (DCI) on CT at 1 month."}
• {"endpoint_text":"- → 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.","definition_or_measurement_approach":"Neurological complications measured in ICU: episodes of brain tissue oxygen tension (PtiO2) <20 mmHg and <15 mmHg for ≥15 minutes; total duration of such episodes; number of endovascular treatments; intracranial pressure (ICP) >20 mmHg for ≥15 minutes."}
• {"endpoint_text":"- → Evolution in intensive care: • Number and type of non-neurological complications","definition_or_measurement_approach":"Number and classification of non-neurological complications occurring during ICU stay (as reported in ICU records)."}
• {"endpoint_text":"- → 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) ®)","definition_or_measurement_approach":"Serial measurements of heart rate (HR), mean arterial pressure (MAP), intracranial pressure (ICP), cerebral perfusion pressure (CPP), transcranial Doppler velocities, and cardiac output via TTE or pulse-wave contour with transpulmonary thermodilution (PiCCO®)."}
• {"endpoint_text":"- → Evolution in intensive care: • Number of days in intensive care","definition_or_measurement_approach":"Count of ICU length of stay in days per participant."}
• {"endpoint_text":"- → Evolution in intensive care: • Number of days with mechanical ventilation","definition_or_measurement_approach":"Number of calendar days participant required mechanical ventilation during ICU stay."}
• {"endpoint_text":"- → 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","definition_or_measurement_approach":"Functional outcomes assessed at 1 month, 3 months, 6 months and 1 year using modified Rankin Scale (mRS) and Glasgow Outcome Scale Extended (GOSE); quality of life via SIP-65 at 3, 6 and 12 months; mortality at each timepoint; total days hospitalized."}
• {"endpoint_text":"- → Number of adverse events","definition_or_measurement_approach":"Count and categorization of adverse events (AEs) as recorded per standard safety reporting during the study period."}
• {"endpoint_text":"- → Build up a biocollection for the evaluation of plasma brain biomarkers or other potential biomarkers","definition_or_measurement_approach":"Prospective collection of biological samples (plasma) to create a biobank for later evaluation of plasma brain biomarkers or other biomarkers."}

France

Earliest CTIS Part Ii Submission Date

04-09-2024

Latest Decision Or Authorization Date

16-09-2024

Processing Time Days

12

Number Of Sites

6

Number Of Participants

100

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France