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

Nantes University Hospital (NUH)

Status and phase

Not yet enrolling

Phase 3

Conditions

TBI Traumatic Brain Injury

Treatments

Drug: Hypertonic saline solution

Study type

Interventional

Funder types

Other

Identifiers

NCT07319208

2024-520205-39-00 (EU Trial (CTIS) Number)

RC24_0543

Details and patient eligibility

About

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.

Enrollment

760 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient admitted to intensive care unit
Traumatic brain injury with Glasgow Coma Scale ≤ 12
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
Inclusion during the first 12 hours after Intracranial pressure monitoring placement
Informed and signed consent
National health insurance

Exclusion criteria

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