Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
Recruiting
Phase 3
Interventional Study
TBI Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 760 (estimated)
- Sponsor
- Nantes University Hospital · Other
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About This Trial
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.
Trial Locations
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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 intra…
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