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Early continuous hypertonic saline infusion to improve 6-month neurological outcome after traumatic brain injury

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.

Phase 3 Interventional Nantes University Hospital · NCT07319208

This trial will test whether giving a continuous intravenous infusion of hypertonic saline early after traumatic brain injury helps people survive and regain independence in daily life at 6 months.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment760 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNantes University Hospital Academic / other
Locations23 sites (Angers and 22 other locations)
Trial IDNCT07319208 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional trial enrolls intensive care patients with traumatic brain injury at high risk of intracranial hypertension who have intracranial pressure monitoring. Participants receive an early continuous intravenous infusion of hypertonic saline solution, started within the first 12 hours after ICP monitor placement, and are followed for clinical outcomes. The primary focus is on survival and independence in daily activities at 6 months. The trial is led by Nantes University Hospital and conducted at multiple French university hospitals.

Who should consider this trial

Good fit: Ideal candidates are ICU patients with traumatic brain injury and Glasgow Coma Scale ≤ 12 who undergo intracranial pressure monitoring and can be enrolled within 12 hours of monitor placement, with appropriate consent and French national health insurance.

Not a fit: Patients unlikely to benefit include those with unsurvivable injury (GCS 3 with persistent nonreactive pupils despite treatment), coma from cardiac arrest, major spinal cord injury, or severe cardiac, renal, or hepatic failure, and pregnant patients who are excluded.

Why it matters

Potential benefit: If successful, this approach could increase survival and improve functional independence at six months for patients with traumatic brain injury and high risk of intracranial hypertension.

How similar studies have performed: Hypertonic saline is widely used to lower intracranial pressure and short-term studies show benefit for ICP control, but strong phase 3 evidence showing improved long-term functional outcomes is limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Angers and 22 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions TBI Traumatic Brain InjuryTraumatic brain injurySaline SolutionHypertonic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.