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Search / Trial NCT04141371

Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Oct 25, 2019

Trial Information

Current as of May 19, 2025

Completed

Keywords

ClinConnect Summary

This clinical trial, titled "Molar Sodium Lactate Filling in Severe Meningeal Hemorrhage," is investigating the potential benefits of sodium lactate for patients experiencing a specific type of brain bleeding called subarachnoid hemorrhage, often caused by a ruptured aneurysm. This condition can lead to serious complications, including vasospasm, which can worsen the patient's condition and lead to long-term neurological issues. The trial aims to compare the effects of sodium lactate with a placebo (a substance with no therapeutic effect) on blood flow in the brain, using a special imaging technique called perfusion CT.

To participate in this study, individuals must be over 18 years old and have a severe type of meningeal hemorrhage, as determined by a specific scoring system. They should have received treatment, such as surgery or endovascular embolization, within 48 hours of the bleeding event. The study is currently recruiting participants, and those who qualify will be asked to give their consent or have their family members provide it if they are unable to respond due to their medical condition. Participants can expect careful monitoring and will help researchers understand whether sodium lactate can help prevent complications from this serious condition.

Gender

ALL

Eligibility criteria

  • 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

About Centre Hospitalier Universitaire De Nice

The Centre Hospitalier Universitaire (CHU) de Nice is a leading academic medical center located in Nice, France, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, CHU de Nice is committed to enhancing patient care by conducting rigorous studies that explore new therapies and treatment modalities across various medical disciplines. With a focus on collaboration, the center integrates cutting-edge technology and interdisciplinary expertise to ensure the highest standards of research integrity and patient safety. CHU de Nice plays a vital role in the development of evidence-based medicine, contributing significantly to the global medical community.

Locations

Nice, , France

Nice, , France

Marseille, , France

Grenoble, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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