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

April 23, 2026 updated by: Nantes University Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

760

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • Patient who does not speak French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypertonic Saline Solution
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of early continuous of HSS
Time Frame: 3 months
Survival : number of patients still alive
3 months
Efficacy of early continuous of HSS
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment of intracranial hypertension
Time Frame: 7 days
Evolution of blood sodium level
7 days
Treatment of intracranial hypertension
Time Frame: 7 days
Evolution of blood chloride level
7 days
Treatment of intracranial hypertension
Time Frame: 7 days
Evolution of solute concentration in blood plasma
7 days
Neurological recovery
Time Frame: 7 days
Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.
7 days
Neurological recovery
Time Frame: until 12 months
Survival : number of patients still alive
until 12 months
Quality of life
Time Frame: until 12 month
Score of EQ-5D-5L (5-level EuroQol-5D version) : minimum - maximal values: 1-5, higher scores mean a worse outcome.
until 12 month
Quality of life
Time Frame: until 12 months
Rates of patient living at home, at rehabilitation centers or at hospital
until 12 months
Anterograde amnesia
Time Frame: until 6 months
Galveston Orientation and Amnesia Test (G.O.A.T) : minimum - maximal values: 0-100, higher scores mean a better outcome.
until 6 months
Neurocognitive functioning
Time Frame: 6 months
Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome.
6 months
Neurological outcome
Time Frame: 6 months
Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome.
6 months
Tolerance
Time Frame: 1 month
Rates severe hypernatremia (Na> 160 mmol/L)
1 month
Tolerance
Time Frame: 1 month
Rates of acute kidney injury
1 month
Tolerance
Time Frame: 1 month
Number of thrombotic events
1 month
Tolerance
Time Frame: 1 month
Number of entral-pontine myelinolysis
1 month
Cost-effectiveness analysis
Time Frame: 12 months
Incremental cost-effectiveness ratio
12 months
Genetic biomarkers
Time Frame: 12 months
Single nucleotide polymorphism
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC24_0543
  • 2024-520205-39-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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