Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141371
• Other study ID #: 19-PP-15
• Status: Recruiting
• Phase: Phase 3
• Start date: February 14, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Carole ICHAI, ph
• Phone: 33492037777
• Email: ichai.c[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: January 1, 2025
• Est. primary completion date: May 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Drug:
• Molar Sodium Lactate
daily 3-hour infusion of sodium molar lactate during the vasospasm period
• physiological serum
daily saline infusion over 3 hours during the vasospasm period

Locations

Country	Name	City	State
France	Grenoble Hospital	Grenoble
France	Marseille Hospital	Marseille
France	Carole ICHAI	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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