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NCT07319208: COSMOS-TBI
Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
Phase 3 trial testing Hypertonic saline solution in TBI Traumatic Brain Injury in 760 participants. Currently enrolling.
1 June 2028
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 760 |
| Start date | 1 May 2026 |
| Primary completion | 1 June 2028 |
| Estimated completion | 1 June 2029 |
| Sites | 23 locations across France |
Drugs / interventions tested
- Hypertonic saline solution
Conditions studied
- TBI Traumatic Brain Injury — all drugs for TBI Traumatic Brain Injury →
Sponsor
Nantes University Hospital
Who can join
Adults 18 to 75, any sex, with TBI Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07319208
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Hypertonic saline solution
Trials testing the same drug.
- NCT03409237 — Coagulation Activation by Hyperosmolar Agents in Intracranial Hypertension · withdrawn
- NCT04785755 — Effects of Adding Hypertonic Saline Solutions and/or Etilefrine to Standard Diuretics Therapy in Hepatic Ascites · Phase 2 · completed
Other recruiting trials for TBI Traumatic Brain Injury
Currently open trials in the same condition.
- NCT07214415 — Veterans' Cognitive Function, Mental Health, and Quality of Life After Hyperbaric Oxygen Therapy · Phase 2 · recruiting
- NCT06818864 — DBS for Cognitive Deficits After Traumatic Brain Injury · Phase 1 · recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
- NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
- NCT06681363 — Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelod · not yet recruiting
- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
- NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07319208 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07319208.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing