Clinical Trial

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

Study acronym: COSMOS-TBI
Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Recruitment opened 2026-04-07
notable Primary completion pushed: 2028-02-01 -> 2028-06-01 2026-04-07
minor Completion pushed: 2029-02-01 -> 2029-06-01 2026-04-07
Trial Details
NCT Number NCT07319208
Lead Sponsor Nantes University Hospital
Conditions TBI Traumatic Brain Injury
Enrollment 760 participants
Start Date 2026-04-21
Primary Completion 2028-06-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-29