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NCT Number: NCT07319208

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU d'Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline solution

Drug

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

Primary outcomes

  1. Efficacy of early continuous of HSS

    Time frame: 3 months

    Survival : number of patients still alive

  2. 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.

Secondary outcomes

  1. Treatment of intracranial hypertension

    Time frame: 7 days

    Evolution of blood sodium level

  2. Treatment of intracranial hypertension

    Time frame: 7 days

    Evolution of blood chloride level

  3. Treatment of intracranial hypertension

    Time frame: 7 days

    Evolution of solute concentration in blood plasma

  4. Neurological recovery

    Time frame: 7 days

    Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.

  5. Neurological recovery

    Time frame: until 12 months

    Survival : number of patients still alive

  6. 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.

  7. Quality of life

    Time frame: until 12 months

    Rates of patient living at home, at rehabilitation centers or at hospital

  8. 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.

  9. Neurocognitive functioning

    Time frame: 6 months

    Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome.

  10. Neurological outcome

    Time frame: 6 months

    Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome.

  11. Tolerance

    Time frame: 1 month

    Rates severe hypernatremia (Na> 160 mmol/L)

  12. Tolerance

    Time frame: 1 month

    Rates of acute kidney injury

  13. Tolerance

    Time frame: 1 month

    Number of thrombotic events

  14. Tolerance

    Time frame: 1 month

    Number of entral-pontine myelinolysis

  15. Cost-effectiveness analysis

    Time frame: 12 months

    Incremental cost-effectiveness ratio

  16. Genetic biomarkers

    Time frame: 12 months

    Single nucleotide polymorphism

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine ROQUILLY

CONTACT

[email protected]

+33 2 53 48 22 30

Astrid GARREAU

CONTACT

[email protected]

+33 2 53 48 28 40

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: COSMOS-TBI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jan 6, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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