Cerebral Hemodynamic Optimization by Milrinone to Prevent Delayed Cerebral Ischemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

The present study is a randomized, multi-center, double-blind, prospective study that tests the efficacy of intravenous milrinone to optimize cerebral hemodynamic and prevent delayed cerebral ischemia (DCI) during the high-risk period (day 4- day 14) in patients with severe subarachnoid hemorrhage due to intracranial aneurysm rupture (SAHa) (WFNS IV-V). The main objective is to 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 CT scan at 1 month.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with severe SAHa (WFNS IV and V,) whose neurological examination is impossible because of coma (Glasgow coma score of 8 or less) or need for sedation at D3

absence of pre-existing neurological handicap (mRS 0-2)

major patient (≥ 18 years)

affiliation to social security or benefiting through a third person

Disqualifiers

patients with non-severe SAHa (WFNS I, II and III)

Occurrence of a major complication (haemorrhagic or ischaemic) documented during the procedure of securing the aneurysm and endangering the short-term vital prognosis

heart failure requiring inotropic administration at the time of randomization

ICHT at the time of randomisation (ICP> 25 mmHg for at least 20 min)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Milrinone Injection

    Drug

    administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14

  • Placebo

    Other intervention

    administration of placebo (intravenous glucose 5%) from Day 4 to Day 14

Treatment groups

234 Participants
are divided into 2 treatment groups
Group A: MilrinoneExperimental treatment 1 intervention
Group B: Standard CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

volume of delayed cerebral ischemia lesions

volume of DCI lesions measured on CT scan and validated by Magnetic Resonance Imaging (MRI) imaging at 1 month

Time frame
1 month

Secondary outcomes

1

Radiological parameters on CT at 1 month

percentage of patients with DCI lesions

Time frame
1 month
2

Evolution in intensive care: Neurological complications 1

number of episodes of PtiO2 below the ischemic threshold in intensive care: PtiO2 \<20 mmHg (moderate hypoxia) and \<15 mm Hg (severe hypoxia) for at least 15 minutes

Time frame
1 month
3

Evolution in intensive care: Neurological complications 2

total duration of episodes of PtiO2 \<20 mm Hg (moderate hypoxia) and \<15 mm Hg (severe hypoxia)

Time frame
1 month
4

Evolution in intensive care: Neurological complications 3

number of recourse to an endovascular treatment

Time frame
1 month

Other outcomes

Sponsors and contacts

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