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

July 27, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
760

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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