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Tests treatment safety and results for TBI Traumatic Brain Injury
Official title Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
ClinicalTrials.gov ID: NCT07319208
What this study is testing
What is Hypertonic saline solution?
Hypertonic saline solution is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for tbi traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Inclusion during the first 12 hours after Intracranial pressure monitoring placement
- Informed and signed consent
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Brest, France
- Caen, France
- Clermont-Ferrand, France
- Clichy, France
- Créteil, France
- Épagny, France
- Grenoble, France
- Lille, France
- Lyon, France
- Marseille, France
- Nancy, France
- Nantes, France
- Nice, France
- Paris, France
- Poitiers, France
- Rennes, France
- Rouen, France
- Saint-Etienne, France
- Strasbourg, France
+ 2 more site(s).
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Brest, France; Caen, France; Clermont-Ferrand, France; Clichy, France; Créteil, France and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.