TBI Traumatic Brain InjuryPhase 3COSMOS-TBINCT07319208
Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
A Phase 3 study testing Hypertonic saline solution in people with TBI Traumatic Brain Injury, run by Nantes University Hospital at 23 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- TBI Traumatic Brain Injury
- What is being tested?
- Hypertonic saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 23 sitesFrance
- Study dates
- 21 Apr 2026to 1 Jun 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
23 sites in 1 country. Contact the study team or a site near you to ask about taking part.
23 sites in 1 country
France23 sites, 23 recruiting
- Not yet recruiting
CHU d'Angers
Angers
Sigismond LASOCKI, silasocki@chu-angers.fr
- Recruiting
CHU de Brest
Brest
Marwan BOURAS, marwan.bouras@chu-brest.fr
- Recruiting
CHU Caen Normandie
Caen
Jean-Luc HANOUZ, hanouz-jl@chu-caen.fr
- Recruiting
CHU de Clermont- Ferrand
Clermont-Ferrand
Benjamin RIEU, brieu@chu-clermontferrand.fr
Russel CHABANNE, rchabanne@chu-clermontferrand.fr
- Recruiting
Hôpital BEAUJON APHP
Clichy
Anais CODORNIU, anais.codorniu@aphp.fr
- Recruiting
CHU Henri Mondor APHP
Créteil
Nicolas MONGARDON, nicolas.mongardon@aphp.fr
- Not yet recruiting
CH de Annecy Genevois
Épagny
Marc VINCLAIR, mvinclair@ch-annecygenevois.fr
- Not yet recruiting
CHU de Grenoble
Grenoble
Tobbias GAUSS, tgauss@chu-grenoble.fr
- Recruiting
CHU de Lille
Lille
Natalie DE SA, natalie.desa@chu-lille.fr
- Not yet recruiting
HCL
Lyon
Baptiste BALANCA, baptiste.balanca@chu-lyon.fr
- Not yet recruiting
AP-HM
Marseille
Marc LEONE, marc.leone@ap-hm.fr
- Not yet recruiting
CHU de Nancy
Nancy
Emmanuel NOVY, e.novy@chru-nancy.fr
- Recruiting
CHU de Nantes
Nantes
Yannick HOURMANT, +33240087380, yannick.hourmant@chu-nantes.fr
- Recruiting
CHU de Nice
Nice
Eve-Marie MAIZIERE, maiziere.em@chu-nice.fr
- Not yet recruiting
CHU Lariboisière, AP-HP
Paris
Benjamin Glenn CHOUSTERMAN, benjamin.chousterman@aphp.fr
- Not yet recruiting
GHU Paris Cité
Paris
Aurélien MAZERAUD, a.mazeraud@ghu-paris.fr
- Not yet recruiting
CHU de Poitiers
Poitiers
Claire DAHYOT- FIZELIER, claire.dahyot-fizelier@chu-poitiers.fr
- Recruiting
CHU de Rennes
Rennes
Yoann LAUNEY, yoann.launey@chu-rennes.fr
- Not yet recruiting
CHU de Rouen
Rouen
Laurent CLOTTEAU, laurent.clotteau@chu-rouen.fr
- Not yet recruiting
CHU de St- Etienne
Saint-Etienne
Jérôme MOREL, jerome.morel@chu-st-etienne.fr
- Not yet recruiting
CHU de Strasbourg
Strasbourg
Baptiste BOUCHIER, baptiste.bouchier@chru-strasbourg.fr
- Recruiting
CHU de Toulouse
Toulouse
Pierre GOUDY, goudy.p@chu-toulouse.fr
- Not yet recruiting
CHRU de Tours
Tours
Benoît COHEN, b.cohen@chu-tours.fr
About this study
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.
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
- Being tested
- Hypertonic saline solution
- Keywords
- Traumatic brain injury, Saline Solution, Hypertonic
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline solutionDrug
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic Saline Solution | Experimental | Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension) Receives: Drug: Hypertonic saline solution |
| Standard | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of early continuous of HSS
Survival : number of patients still alive
Measured: 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.
Measured: 6 months
Secondary outcomes (16)
Treatment of intracranial hypertension
Evolution of blood sodium level
Measured: 7 days
Treatment of intracranial hypertension
Evolution of blood chloride level
Measured: 7 days
Treatment of intracranial hypertension
Evolution of solute concentration in blood plasma
Measured: 7 days
Neurological recovery
Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.
Measured: 7 days
Neurological recovery
Survival : number of patients still alive
Measured: until 12 months
Quality of life
Score of EQ-5D-5L (5-level EuroQol-5D version) : minimum - maximal values: 1-5, higher scores mean a worse outcome.
Measured: until 12 month
Quality of life
Rates of patient living at home, at rehabilitation centers or at hospital
Measured: until 12 months
Anterograde amnesia
Galveston Orientation and Amnesia Test (G.O.A.T) : minimum - maximal values: 0-100, higher scores mean a better outcome.
Measured: until 6 months
Neurocognitive functioning
Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome.
Measured: 6 months
Neurological outcome
Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome.
Measured: 6 months
Tolerance
Rates severe hypernatremia (Na> 160 mmol/L)
Measured: 1 month
Tolerance
Rates of acute kidney injury
Measured: 1 month
Tolerance
Number of thrombotic events
Measured: 1 month
Tolerance
Number of entral-pontine myelinolysis
Measured: 1 month
Cost-effectiveness analysis
Incremental cost-effectiveness ratio
Measured: 12 months
Genetic biomarkers
Single nucleotide polymorphism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start21 Apr 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, Single insulated with blinded assessment of the primary endpoint, Prospective
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319208
- Sponsor's protocol ID
- RC24_0543
- Other IDs
- 2024-520205-39-00
- Acronym
- COSMOS-TBI
- Status last verified
- Jul 2026
- First submitted
- 1 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07319208
- Acronym / sponsor ID
- COSMOS-TBI / RC24_0543
- Conditions
- TBI Traumatic Brain Injury
- Keywords
- Traumatic brain injury, Saline Solution, Hypertonic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled, Single insulated with blinded assessment of the primary endpoint, Prospective
| Arm | Type | Receives |
|---|---|---|
| Hypertonic Saline Solution | Experimental | Drug: Hypertonic saline solutionContinuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension) |
| Standard | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic saline solutionContinuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension) | Drug | Hypertonic Saline Solution |
Primary outcome
Efficacy of early continuous of HSS
Time frame: 3 months
Survival : number of patients still alive
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.
16 secondary outcomes
Treatment of intracranial hypertension
Time frame: 7 days
Treatment of intracranial hypertension
Time frame: 7 days
Treatment of intracranial hypertension
Time frame: 7 days
Neurological recovery
Time frame: 7 days
Neurological recovery
Time frame: until 12 months
Quality of life
Time frame: until 12 month
Quality of life
Time frame: until 12 months
Anterograde amnesia
Time frame: until 6 months
Neurocognitive functioning
Time frame: 6 months
Neurological outcome
Time frame: 6 months
Tolerance
Time frame: 1 month
Tolerance
Time frame: 1 month
Tolerance
Time frame: 1 month
Tolerance
Time frame: 1 month
Cost-effectiveness analysis
Time frame: 12 months
Genetic biomarkers
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for TBI Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic saline solution in people with TBI Traumatic Brain Injury, run by Nantes University Hospital at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine ROQUILLY (+33 2 53 48 22 30, antoine.roquilly@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of early continuous of HSS (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.