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

RecruitingPhase 3Ages 18 Years - 75 YearsAllNantes University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Hypertonic saline solution
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Where

23 sites
CHU d'Angers
Angers, France
CHU de Brest
Brest, France
CHU Caen Normandie
Caen, France
CHU de Clermont- Ferrand
Clermont-Ferrand, France
Hôpital BEAUJON APHP
Clichy, France
CHU Henri Mondor APHP
Créteil, France
CH de Annecy Genevois
Épagny, France
CHU de Grenoble
Grenoble, France

…and 15 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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