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
1 other identifier
interventional
3
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2019
CompletedFirst Posted
Study publicly available on registry
October 28, 2019
CompletedStudy Start
First participant enrolled
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2024
CompletedMarch 19, 2025
March 1, 2025
3 months
October 25, 2019
March 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Molar Sodium Lactate
ACTIVE COMPARATORphysiological serum
PLACEBO COMPARATORInterventions
daily 3-hour infusion of sodium molar lactate during the vasospasm period
daily saline infusion over 3 hours during the vasospasm period
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Grenoble Hospital
Grenoble, France
Marseille Hospital
Marseille, 13000, France
Carole ICHAI
Nice, 06000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- paticipant and radiologists are masked
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2019
First Posted
October 28, 2019
Study Start
February 14, 2022
Primary Completion
May 5, 2022
Study Completion
June 7, 2024
Last Updated
March 19, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share