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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Hypertonic saline solution

Treatment groups

760 Participants
are divided into 2 treatment groups

Sponsors and collaborators