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Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients. | Clinical Trials | Clareo Health

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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.

NCT07319208•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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despite urgent therapy
•Associated cervical spinal cord injury
•Imminent death and do-not-resuscitate orders
•Coma secondary to cardiac arrest
•Pregnancy (serum or urine test performed in routine care)
•Severe Cardiac insufficiency
•Severe chronic renal insufficiency
•Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
•High risk of follow-up difficulties after ICU discharge
•Patients under court protection
+1 more criteria

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

Key Dates

Start Date

January 1, 2026

Primary Completion Date

February 1, 2028

Completion Date

February 1, 2029

Last Updated

January 6, 2026

Enrollment

760

ESTIMATED participants

Conditions

TBI Traumatic Brain Injury

Interventions

Hypertonic saline solution

DRUG

Contacts

Antoine ROQUILLY

CONTACT

+33 2 53 48 22 30 antoine.roquilly@chu-nantes.fr

Astrid GARREAU

CONTACT

+33 2 53 48 28 40 astrid.garreau@chu-nantes.fr

Evaluating the Impact of Adjuvant Use of Beta Blockers on Clinical Outcomes in Patients With Traumatic Brain Injury

NCT06836856

TBI Traumatic Brain Injury

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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