Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
NCT ID: NCT07319208
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
760 participants
INTERVENTIONAL
2026-01-01
2029-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hypertonic Saline Solution
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Hypertonic saline solution
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Standard
Standard of care
No interventions assigned to this group
Interventions
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Hypertonic saline solution
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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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
CHU de Lille
Lille, , France
HCL
Lyon, , France
AP-HM
Marseille, , France
CHU de Nancy
Nancy, , France
CHU de Nantes
Nantes, , France
CHU de Nice
Nice, , France
CHU Lariboisière, AP-HP
Paris, , France
GHU Paris Cité
Paris, , France
CHU de Poitiers
Poitiers, , France
CHU de Rennes
Rennes, , France
CHU de Rouen
Rouen, , France
CHU de St- Etienne
Saint-Etienne, , France
CHU de Strasbourg
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
CHRU de Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-520205-39-00
Identifier Type: CTIS
Identifier Source: secondary_id
RC24_0543
Identifier Type: -
Identifier Source: org_study_id
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