NCT07319208 Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
| NCT ID | NCT07319208 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Nantes University Hospital |
| Condition | TBI Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 760 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 760 participants in total. It began in 2026-04-21 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07319208 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying TBI Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07319208 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 760 participants.
Is NCT07319208 currently recruiting?
Yes, NCT07319208 is actively recruiting participants. Contact the research team at antoine.roquilly@chu-nantes.fr for enrollment information.
Where is the NCT07319208 trial being conducted?
This trial is being conducted at Angers, France, Brest, France, Caen, France, Clermont-Ferrand, France and 11 additional locations.
Who is sponsoring the NCT07319208 clinical trial?
NCT07319208 is sponsored by Nantes University Hospital. The trial plans to enroll 760 participants.