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Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
Sponsor: Nantes University Hospital
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
760
Start Date
2026-05-01
Completion Date
2029-06-01
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Hypertonic 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