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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.
EU CTIS ID: 2024-520205-39-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age between 18 – 75 years old
- Patient admitted to intensive care unit
- Traumatic brain injury with Glasgow Coma Scale ≤ 12
- Inclusion during the first 12 hours after Intracranial pressure monitoring placement
- Informed and signed consent
- National health insurance
You likely can't join if
- Glasgow Coma Scale (score = 3) and persistent abnormal pupillary reactivity despite urgent therapy
- Patients under court protection
- Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
- Patient who does not speak French
- Associated cervical spinal cord injury
- Imminent death and do-not-resuscitate ordersc
See the full eligibility criteria
- Age between 18 – 75 years old
- Patient admitted to intensive care unit
- Traumatic brain injury with Glasgow Coma Scale ≤ 12
- Inclusion during the first 12 hours after Intracranial pressure monitoring placement
- Informed and signed consent
- National health insurance
- 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
- Glasgow Coma Scale (score = 3) and persistent abnormal pupillary reactivity despite urgent therapy
- Patients under court protection
- Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
- Patient who does not speak French
- Associated cervical spinal cord injury
- Imminent death and do-not-resuscitate ordersc
- Coma secondary to cardiac arrest
- Pregnancy (serum or urine test performed in routine care)
- Severe Cardiac insufficiency
- Severe chronic renal insufficiency
- High risk of follow-up difficulties after ICU discharge
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.