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RECRUITING
NCT07319208
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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