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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Brest
  Brest, France Recruiting
• CHU Caen Normandie
  Caen, France Recruiting
• CHU de Clermont- Ferrand
  Clermont-Ferrand, France Recruiting
• Hôpital BEAUJON APHP
  Clichy, France Recruiting
• CHU Henri Mondor APHP
  Créteil, France Recruiting
• CHU de Lille
  Lille, France Recruiting

Study contacts

• Study coordinator: Antoine ROQUILLY
• Email: antoine.roquilly@chu-nantes.fr
• Phone: +33 2 53 48 22 30

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.