NCT07319208

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

Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients. A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial With Blinded Evaluation of the Primary Outcome.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• TBI Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	Hypertonic saline solution	Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2026-01-06
• Last updated: 2026-04-06

Locations

23 sites across 1 country: France