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

Name: Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients. — clinical trial record (NCT07319208)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: COSMOS-TBI

StatusRecruiting

PhasePhase 3

SponsorNantes University Hospital

Started2026-04-21

View on ClinicalTrials.gov ↗

Amendment history

2026-07-27

Study Status, Contacts/Locations v3

Study sitesdetails revised at 9 of 23 sites

2026-04-23

Study Status v2

Start dateestimated 2026-05-01→confirmed 2026-04-21

2026-03-31

Study Status, Contacts/Locations v1

Recruitment opened

Primary completion pushed: 2028-02-01 → 2028-06-01

Completion pushed: 2029-02-01 → 2029-06-01

Start date2026-01-01→2026-05-01

Study sitesdetails revised at 23 of 23 sites

2025-12-19

Original filing

Nantes University Hospital

356 trials monitored

See 13 trials at risk

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 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