Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

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

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.

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Hemorrhage, Aneurysmal
• Intervention / Treatment: Drug: Molar Sodium Lactate; Drug: physiological serum

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Carole ICHAI, ph; Phone Number: 33492037777; Email: ichai.c@chu-nice.fr

Study Locations

• France
  • Grenoble, France
    • Not yet recruiting
    • Grenoble Hospital
    • Contact: jean francois payen, puph; Phone Number: 33476766890
    • Principal Investigator: jean francois payen
  • Marseille, France, 13000
    • Not yet recruiting
    • Marseille Hospital
    • Contact: lionel velly, ph; Phone Number: 33491324053
    • Principal Investigator: lionel velly, ph
  • Nice, France, 06000
    • Recruiting
    • Carole ICHAI
    • Contact: Carole ICHAI, PH; Email: Ichai.c@chu-nice.fr
    • Principal Investigator: carole ichai, PUPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): May 5, 2022
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 19-PP-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No