RecruitingPhase 3NCT07319208

Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.

Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients. A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial With Blinded Evaluation of the Primary Outcome.


Sponsor

Nantes University Hospital

Enrollment

760 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hypertonic saline solution for people with tbi (traumatic brain injury). The study is currently recruiting participants at 23 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHypertonic saline solution

Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)


Locations(23)

CHU d'Angers

Angers, France

CHU de Brest

Brest, France

CHU Caen Normandie

Caen, France

CHU de Clermont- Ferrand

Clermont-Ferrand, France

Hôpital BEAUJON APHP

Clichy, France

CHU Henri Mondor APHP

Créteil, France

CH de Annecy Genevois

Épagny, France

CHU de Grenoble

Grenoble, France

CHU de Lille

Lille, France

HCL

Lyon, France

AP-HM

Marseille, France

CHU de Nancy

Nancy, France

CHU de Nantes

Nantes, France

CHU de Nice

Nice, France

CHU Lariboisière, AP-HP

Paris, France

GHU Paris Cité

Paris, France

CHU de Poitiers

Poitiers, France

CHU de Rennes

Rennes, France

CHU de Rouen

Rouen, France

CHU de St- Etienne

Saint-Etienne, France

CHU de Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France

CHRU de Tours

Tours, France

View Full Details on ClinicalTrials.gov

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NCT07319208


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