Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 3

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Treatments: Drug: physiological serum; Drug: Molar Sodium Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT04141371

19-PP-15

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups, including a placebo group

Molar Sodium Lactate

Active Comparator group

Treatment:

Drug: Molar Sodium Lactate

physiological serum

Placebo Comparator group

Treatment:

Drug: physiological serum