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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

21 Apr 2026 → ongoing

Decision date (initial)

2025-08-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 4

1. To demonstrate the efficacy of a continuous infusion of HSS on the prevention and treatment of intracranial hypertension (intermediate endpoint) and the neurological recovery and the quality of life at 6 months.
2. To study the tolerance of the treatment.
3. To perform a cost-effectiveness analysis with a 12-month perspective (evaluate the economic efficiency).
4. Identification of genetic biomarkers associated with response to treatment and long-term recovery.

Conditions and MedDRA coding

Traumatic brain injury

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age between 18 – 75 years old
2. Patient admitted to intensive care unit
3. Traumatic brain injury with Glasgow Coma Scale ≤ 12
4. Inclusion during the first 12 hours after Intracranial pressure monitoring placement
5. Informed and signed consent
6. National health insurance
7. Intracranial pressure (ICP) monitoring based on the attending physician’s clinical judgment, in accordance with guidelines or clinical/radiological signs considered at risk of intracranial hypertension

Exclusion criteria 11

1. Glasgow Coma Scale (score = 3) and persistent abnormal pupillary reactivity despite urgent therapy
2. Patient who does not speak French
3. Associated cervical spinal cord injury
4. Imminent death and do-not-resuscitate ordersc
5. Coma secondary to cardiac arrest
6. Pregnancy (serum or urine test performed in routine care)
7. Severe Cardiac insufficiency
8. Severe chronic renal insufficiency
9. High risk of follow-up difficulties after ICU discharge
10. Patients under court protection
11. Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.

Secondary endpoints 12

1. Evolution of natremia, chloremia, and plasma osmolarity (7 days)
2. Therapeutic intensity level during the first 7 days
3. Survival at 1, 6 and 12 months
4. EQ-5D-5L at 1, 3, 6 and 12 months (quality-adjusted life year)
5. Residency at 1, 3, 6 and 12 months
6. G.O.A.T at 1, 3 and 6 months
7. MOCA, GOS-E at 6 months
8. Rates severe hypernatremia (Na> 160 mmol/L) at Month 1
9. Rates of acute kidney injury at Month 1 (KDIGO score 2-3)
10. Safety (thrombotic events, central-pontine myelinolysis)
11. Incremental cost-effectiveness ratio with a one-year time horizon
12. Single nucleotide polymorphism correlated with the clinical outcome

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Pr Antoine ROQUILLY

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Pr Antoine ROQUILLY

Locations

1 EU/EEA country · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications