Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-14

Study Completion Date

2024-06-07

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.

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Detailed Description

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Conditions

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Subarachnoid Hemorrhage, Aneurysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

paticipant and radiologists are masked

Study Groups

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Molar Sodium Lactate

Group Type ACTIVE_COMPARATOR

Molar Sodium Lactate

Intervention Type DRUG

daily 3-hour infusion of sodium molar lactate during the vasospasm period

physiological serum

Group Type PLACEBO_COMPARATOR

physiological serum

Intervention Type DRUG

daily saline infusion over 3 hours during the vasospasm period

Interventions

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Molar Sodium Lactate

daily 3-hour infusion of sodium molar lactate during the vasospasm period

Intervention Type DRUG

physiological serum

daily saline infusion over 3 hours during the vasospasm period

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No