Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Study Overview
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Brief Summary
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Subarachnoid hemorrhage by aneurysmal rupture is a serious condition associated with a high mortality rate. Among the complications presented by these patients, vasospasm is one of the main causes of secondary aggravation, in particular the appearance of delayed neurological deficits following the induced cerebral ischemia. Classically occurring between the 4th and 12th day, with a peak on D7, its prevention is currently often ineffective. In recent years, many studies have shown that sodium lactate could be an interesting product for neuroprotection. In addition to an anti-osmotic effect that has been demonstrated by our team in the context of post-traumatic intracranial hypertension, a metabolic action has also been observed in periods of metabolic attacks induced by brain attacks. Recently, a vasodilatory action of sodium lactate has been observed from an experimental and clinical point of view. The purpose of this work is to observe the effect of sodium lactate, compared to placebo, on cerebral hemodynamics measured by perfusion CT (Mean Transit Time MTT) in a population of patients with hemorrhage under the arachnoid. This work is the preliminary work of a study that will investigate the potential preventive protective effect of sodium lactate on the incidence of vasospasm.

Official Title
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Effect of Molar Sodium Lactate Filling on Cerebral Hemodynamics in Patients With Severe Meningeal Hemorrhage Multicenter Randomized Study

Conditions
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Subarachnoid Hemorrhage, Aneurysmal

Intervention / Treatment
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* Drug: Molar Sodium Lactate
* Drug: physiological serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient over 18 years of age with severe meningeal hemorrhage defined by a WFNS≥3 score will be included in the study. Treated by endovascular embolization or surgically within 48 hours After obtaining the informed consent of the patient, or his relatives if he is not searchable (coma). Affiliation to a social security system After an adapted preliminary medical examination Exclusion Criteria: Post-traumatic meningeal hemorrhage Management time >48h with respect to bleeding Known neurodegenerative pathology (Alzheimer's, Parkinson's, etc.), Creutzfeldt-Jacob disease Pregnant woman Decision not to treat Refusal to participate in the study Adult patient protected by law Person deprived of administrative or judicial freedom

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Molar Sodium Lactate<br> | Drug: Molar Sodium Lactate<br>* daily 3-hour infusion of sodium molar lactate during the vasospasm period<br>|
| Placebo Comparator: physiological serum<br> | Drug: physiological serum<br>* daily saline infusion over 3 hours during the vasospasm period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median transit time (MTT) | median transit time (MTT) in seconds, on the perfusion scanner on 6 regions of the brain between D0 and D7 of the product perfusion | 7 days |