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.
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patient admitted to intensive care unit
• Traumatic brain injury with Glasgow Coma Scale ≤ 12
• Intracranial pressure (ICP) monitoring based on the attending physician's clinical judgment, in accordance with guidelines or clinical/radiological signs considered at risk of intracranial hypertension
• Inclusion during the first 12 hours after Intracranial pressure monitoring placement
• Informed and signed consent
• National health insurance
Locations
Other Locations
France
CHU d'Angers
NOT_YET_RECRUITING
Angers
CHU de Brest
NOT_YET_RECRUITING
Brest
CHU Caen Normandie
NOT_YET_RECRUITING
Caen
CHU de Clermont- Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
Hôpital BEAUJON APHP
NOT_YET_RECRUITING
Clichy
CHU Henri Mondor APHP
NOT_YET_RECRUITING
Créteil
CH de Annecy Genevois
NOT_YET_RECRUITING
Épagny
CHU de Grenoble
NOT_YET_RECRUITING
Grenoble
CHU de Lille
NOT_YET_RECRUITING
Lille
HCL
NOT_YET_RECRUITING
Lyon
AP-HM
NOT_YET_RECRUITING
Marseille
CHU de Nancy
NOT_YET_RECRUITING
Nancy
CHU de Nantes
RECRUITING
Nantes
CHU de Nice
NOT_YET_RECRUITING
Nice
CHU Lariboisière, AP-HP
NOT_YET_RECRUITING
Paris
GHU Paris Cité
NOT_YET_RECRUITING
Paris
CHU de Poitiers
NOT_YET_RECRUITING
Poitiers
CHU de Rennes
NOT_YET_RECRUITING
Rennes
CHU de Rouen
NOT_YET_RECRUITING
Rouen
CHU de St- Etienne
NOT_YET_RECRUITING
Saint-etienne
CHU de Strasbourg
NOT_YET_RECRUITING
Strasbourg
CHU de Toulouse
NOT_YET_RECRUITING
Toulouse
CHRU de Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Antoine ROQUILLY
antoine.roquilly@chu-nantes.fr
+33 2 53 48 22 30
Backup
Astrid GARREAU
astrid.garreau@chu-nantes.fr
+33 2 53 48 28 40
Time Frame
Start Date: 2026-04-21
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 760
Treatments
Experimental: Hypertonic Saline Solution
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
No_intervention: Standard
Standard of care
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital