Clinical trial • Phase III • Neurology
SODIUM CHLORIDE for Traumatic brain injury
Phase III trial of SODIUM CHLORIDE for Traumatic brain injury. Randomised. 760 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Traumatic brain injury
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 28-05-2025
- First CTIS Authorization Date
- 22-08-2025
Trial design
Randomised Phase III trial across 24 sites in France.
- Randomised
- Yes
- Target Sample Size
- 760
- Trial Duration For Participant
- 365
Eligibility
Recruits 760 Vulnerable population flag selected. Inclusion requires "Informed and signed consent". Subject information and informed consent forms available include versions for emergency (URGENCE), proxy/relative (PROCHE), and specific patient/relative forms for minors and continuation (documents listed: L1_SIS and ICF URGENCE, PROCHE, PATIENT_Poursuite_Mineur, PROCHE_Initial_Mineur, etc.). Patients under court protection are explicitly excluded. Consent for incapacitated patients appears to be managed via proxy/legal representative forms (presence of 'PROCHE' and emergency consent documents)..
- Pregnancy Exclusion
- Pregnancy (serum or urine test performed in routine care)
- Vulnerable Population
- Vulnerable population flag selected. Inclusion requires "Informed and signed consent". Subject information and informed consent forms available include versions for emergency (URGENCE), proxy/relative (PROCHE), and specific patient/relative forms for minors and continuation (documents listed: L1_SIS and ICF URGENCE, PROCHE, PATIENT_Poursuite_Mineur, PROCHE_Initial_Mineur, etc.). Patients under court protection are explicitly excluded. Consent for incapacitated patients appears to be managed via proxy/legal representative forms (presence of 'PROCHE' and emergency consent documents).
Inclusion criteria
- {"criterion_text":"- Age between 18 – 75 years old\n- Patient admitted to intensive care unit\n- Traumatic brain injury with Glasgow Coma Scale ≤ 12\n- Inclusion during the first 12 hours after Intracranial pressure monitoring placement\n- Informed and signed consent\n- National health insurance\n- 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"}
Exclusion criteria
- {"criterion_text":"- Glasgow Coma Scale (score = 3) and persistent abnormal pupillary reactivity despite urgent therapy\n- Patients under court protection\n- Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis\n- Patient who does not speak French\n- Associated cervical spinal cord injury\n- Imminent death and do-not-resuscitate ordersc\n- Coma secondary to cardiac arrest\n- Pregnancy (serum or urine test performed in routine care)\n- Severe Cardiac insufficiency\n- Severe chronic renal insufficiency\n- High risk of follow-up difficulties after ICU discharge"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.","definition_or_measurement_approach":"Co-primary endpoints: survival at 3 months; degree of dependency in activities of daily living at 6 months. Both will be assessed centrally by a blinded evaluator."}
Secondary endpoints
- {"endpoint_text":"- Evolution of natremia, chloremia, and plasma osmolarity (7 days)","definition_or_measurement_approach":"Serial measurement of natremia, chloremia and plasma osmolarity over 7 days."}
- {"endpoint_text":"- Therapeutic intensity level during the first 7 days","definition_or_measurement_approach":"Assessment of therapeutic intensity level during initial 7 days (measurement approach not further specified)."}
- {"endpoint_text":"- Survival at 1, 6 and 12 months","definition_or_measurement_approach":"Survival status assessed at 1, 6 and 12 months."}
- {"endpoint_text":"- EQ-5D-5L at 1, 3, 6 and 12 months (quality-adjusted life year)","definition_or_measurement_approach":"Health-related quality of life assessed using EQ-5D-5L at 1, 3, 6 and 12 months to compute QALYs."}
- {"endpoint_text":"- Residency at 1, 3, 6 and 12 months","definition_or_measurement_approach":"Assessment of living situation/residency at specified timepoints."}
- {"endpoint_text":"- G.O.A.T at 1, 3 and 6 months","definition_or_measurement_approach":"G.O.A.T instrument assessed at 1, 3 and 6 months (measurement approach not further specified)."}
- {"endpoint_text":"- MOCA, GOS-E at 6 months","definition_or_measurement_approach":"Cognitive and functional assessments: MOCA and GOS-E at 6 months."}
- {"endpoint_text":"- Rates severe hypernatremia (Na> 160 mmol/L) at Month 1","definition_or_measurement_approach":"Incidence of severe hypernatremia defined as Na > 160 mmol/L at Month 1."}
- {"endpoint_text":"- Rates of acute kidney injury at Month 1 (KDIGO score 2-3)","definition_or_measurement_approach":"Incidence of AKI at Month 1 defined by KDIGO stage 2-3."}
- {"endpoint_text":"- Safety (thrombotic events, central-pontine myelinolysis)","definition_or_measurement_approach":"Safety monitoring for specified adverse events including thrombotic events and central-pontine myelinolysis."}
- {"endpoint_text":"- Incremental cost-effectiveness ratio with a one-year time horizon","definition_or_measurement_approach":"Health economic analysis to derive ICER over one-year horizon."}
- {"endpoint_text":"- Single nucleotide polymorphism correlated with the clinical outcome","definition_or_measurement_approach":"Genetic biomarker analysis to identify SNPs correlated with clinical outcome."}
Recruitment
- Planned Sample Size
- 760
- Recruitment Window Months
- 36
- Consent Approach
- Informed and signed consent is required. The dossier includes multiple subject information and informed consent forms: standard patient forms, emergency (URGENCE) forms, proxy/relative (PROCHE) forms, and specific versions for continuation and for minors (document list includes L1_SIS and ICF variants). For incapacitated patients, proxy/legal representative consent procedures and emergency consent forms are provided. Patients under court protection are excluded. Languages available are not specified in the record.
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 760
France
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 15-01-2026
- Processing Time Days
- 183
- Number Of Sites
- 24
- Number Of Participants
- 760
Sites
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Marwan BOURAS
- Principal Investigator Email
- marwan.bouras@chu-brest.fr
- Contact Person Name
- Marwan BOURAS
- Contact Person Email
- marwan.bouras@chu-brest.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Nicolas MONGARDON
- Principal Investigator Email
- nicolas.mongardon@aphp.fr
- Contact Person Name
- Nicolas MONGARDON
- Contact Person Email
- nicolas.mongardon@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Jean-Luc HANOUZ
- Principal Investigator Email
- hanouz-jl@chu-caen.fr
- Contact Person Name
- Jean-Luc HANOUZ
- Contact Person Email
- hanouz-jl@chu-caen.fr
- Site Name
- Centre Hospitalier Annecy Genevois
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Marc VINCLAIR
- Principal Investigator Email
- mvinclair@ch-annecygenevois.fr
- Contact Person Name
- Marc VINCLAIR
- Contact Person Email
- mvinclair@ch-annecygenevois.fr
- Site Name
- Groupe Hospitalier Universitaire Paris Psychiatrie Et Neuroscience
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Aurélien MAZERAUD
- Principal Investigator Email
- a.mazeraud@ghu-paris.fr
- Contact Person Name
- Aurélien MAZERAUD
- Contact Person Email
- a.mazeraud@ghu-paris.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Jérôme MOREL
- Principal Investigator Email
- jerome.morel@chu-st-etienne.fr
- Contact Person Name
- Jérôme MOREL
- Contact Person Email
- jerome.morel@chu-st-etienne.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Baptiste BALANCA
- Principal Investigator Email
- baptiste.balanca@gmail.com
- Contact Person Name
- Baptiste BALANCA
- Contact Person Email
- baptiste.balanca@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Pierre GOUDY
- Principal Investigator Email
- goudy.p@chu-toulouse.fr
- Contact Person Name
- Pierre GOUDY
- Contact Person Email
- goudy.p@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Marc LEONE
- Principal Investigator Email
- Marc.LEONE@ap-hm.fr
- Contact Person Name
- Marc LEONE
- Contact Person Email
- Marc.LEONE@ap-hm.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Neurochirurgie, Anesthésie- Réanimation
- Principal Investigator Name
- Russel CHABANNE
- Principal Investigator Email
- rchabanne@chu-clermontferrand.fr
- Contact Person Name
- Russel CHABANNE
- Contact Person Email
- rchabanne@chu-clermontferrand.fr
- Site Name
- Hopital Beaujon
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Anais CODORNIU
- Principal Investigator Email
- anais.codorniu@aphp.fr
- Contact Person Name
- Anais CODORNIU
- Contact Person Email
- anais.codorniu@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Natalie DE SA
- Principal Investigator Email
- Natalie.desa@chu-lille.fr
- Contact Person Name
- Natalie DE SA
- Contact Person Email
- Natalie.desa@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Yannick HOURMANT
- Principal Investigator Email
- yannick.hourmant@chu-nantes.fr
- Contact Person Name
- Yannick HOURMANT
- Contact Person Email
- yannick.hourmant@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Eve-Marie MAIZIERE
- Principal Investigator Email
- maiziere.em@chu-nice.fr
- Contact Person Name
- Eve-Marie MAIZIERE
- Contact Person Email
- maiziere.em@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Réanimation chirurgicale, Anesthésie- Réanimation
- Principal Investigator Name
- Laurent CLOTTEAU
- Principal Investigator Email
- Laurent.Clotteau@chu-rouen.fr
- Contact Person Name
- Laurent CLOTTEAU
- Contact Person Email
- Laurent.Clotteau@chu-rouen.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Benoît COHEN
- Principal Investigator Email
- B.COHEN@chu-tours.fr
- Contact Person Name
- Benoît COHEN
- Contact Person Email
- B.COHEN@chu-tours.fr
- Site Name
- CHRU De Nancy
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Emmanuel NOVY
- Principal Investigator Email
- E.NOVY@chru-nancy.fr
- Contact Person Name
- Emmanuel NOVY
- Contact Person Email
- E.NOVY@chru-nancy.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Baptiste BOUCHIER
- Principal Investigator Email
- baptiste.bouchier@chru-strasbourg.fr
- Contact Person Name
- Baptiste BOUCHIER
- Contact Person Email
- baptiste.bouchier@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Claire DAHYOT-FIZELIER
- Principal Investigator Email
- Claire.dahyot-fizelier@chu-poitiers.fr
- Contact Person Name
- Claire DAHYOT-FIZELIER
- Contact Person Email
- Claire.dahyot-fizelier@chu-poitiers.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Benjamin Rieu
- Principal Investigator Email
- brieu@chu-clermontferrand.fr
- Contact Person Name
- Benjamin Rieu
- Contact Person Email
- brieu@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Yoann LAUNEY
- Principal Investigator Email
- Yoann.LAUNEY@chu-rennes.fr
- Contact Person Name
- Yoann LAUNEY
- Contact Person Email
- Yoann.LAUNEY@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Tobbias GAUSS
- Principal Investigator Email
- tgauss@chu-grenoble.fr
- Contact Person Name
- Tobbias GAUSS
- Contact Person Email
- tgauss@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Benjamin Glenn CHOUSTERMAN
- Principal Investigator Email
- benjamin.chousterman@aphp.fr
- Contact Person Name
- Benjamin Glenn CHOUSTERMAN
- Contact Person Email
- benjamin.chousterman@aphp.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Anesthésie- Réanimation
- Principal Investigator Name
- Sigismond LASOCKI
- Principal Investigator Email
- SiLasocki@chu-angers.fr
- Contact Person Name
- Sigismond LASOCKI
- Contact Person Email
- SiLasocki@chu-angers.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Nantes
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- SODIUM CHLORIDE (SOLUTION FOR INJECTION)
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- marketingAuthNumber: -, prodAuthStatus: 2
- Maximum Dose
- maxDailyDoseAmount: 120 g; maxTotalDoseAmount: 663 g
- Investigational Product Name
- SODIUM CHLORIDE (SOLUTION FOR INFUSION)
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- marketingAuthNumber: -, prodAuthStatus: 2
- Maximum Dose
- maxDailyDoseAmount: 60 g; maxTotalDoseAmount: 420 g
- Investigational Product Name
- MANNITOL (SOLUTION FOR INFUSION)
- Active Substance
- MANNITOL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- Intravenous
- Authorisation Status
- marketingAuthNumber: -, prodAuthStatus: 2
- Maximum Dose
- maxDailyDoseAmount: 1 l; maxTotalDoseAmount: 7 l
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