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

NCT07319208 | Recruiting Phase 3

• 2 other identifiers: RC24_05432024-520205-39-00
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 23

Brief 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.

Conditions

TBI Traumatic Brain Injury

Keywords

Traumatic brain injury; Saline Solution; Hypertonic

Outcome Measures

Primary Outcomes (2)

• Efficacy of early continuous of HSS

  Survival : number of patients still alive

  3 months

• Efficacy of early continuous of HSS

  Rate of moderate to no dependency in activities in daily living at 6 months is defined as a Barthel Index of independence in activities in daily living ≥ 61.

  6 months

Secondary Outcomes (16)

• Treatment of intracranial hypertension

  7 days

• Treatment of intracranial hypertension

  7 days

• Treatment of intracranial hypertension

  7 days

• Neurological recovery

  7 days

• Neurological recovery

  until 12 months

Study Arms (2)

Hypertonic Saline Solution

EXPERIMENTAL

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

Drug: Hypertonic saline solution

Standard

NO INTERVENTION

Standard of care

Interventions

Hypertonic saline solution DRUG

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

Hypertonic Saline Solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Informed and signed consent
• National health insurance

You may not qualify if:

• 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
• Patient who does not speak French

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (23)

CHU d'Angers

Angers, France

NOT YET RECRUITING

CHU de Brest

Brest, France

NOT YET RECRUITING

CHU Caen Normandie

Caen, France

NOT YET RECRUITING

CHU de Clermont- Ferrand

Clermont-Ferrand, France

NOT YET RECRUITING

Hôpital BEAUJON APHP

Clichy, France

NOT YET RECRUITING

CHU Henri Mondor APHP

Créteil, France

NOT YET RECRUITING

CH de Annecy Genevois

Épagny, France

NOT YET RECRUITING

CHU de Grenoble

Grenoble, France

NOT YET RECRUITING

CHU de Lille

Lille, France

NOT YET RECRUITING

HCL

Lyon, France

NOT YET RECRUITING

AP-HM

Marseille, France

NOT YET RECRUITING

CHU de Nancy

Nancy, France

NOT YET RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

CHU de Nice

Nice, France

NOT YET RECRUITING

CHU Lariboisière, AP-HP

Paris, France

NOT YET RECRUITING

GHU Paris Cité

Paris, France

NOT YET RECRUITING

CHU de Poitiers

Poitiers, France

NOT YET RECRUITING

CHU de Rennes

Rennes, France

NOT YET RECRUITING

CHU de Rouen

Rouen, France

NOT YET RECRUITING

CHU de St- Etienne

Saint-Etienne, France

NOT YET RECRUITING

CHU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, France

NOT YET RECRUITING

CHRU de Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, Single insulated with blinded assessment of the primary endpoint, Prospective

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 6, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (23)