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Clinical Trials/NCT07319208
NCT07319208
Recruiting
Phase 3

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.

Nantes University Hospital40 sites in 1 country760 target enrollmentStarted: May 1, 2026Last updated:
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InterventionsHypertonic saline solution

Overview

Phase
Phase 3
Status
Recruiting
Enrollment
760
Locations
40
Primary Endpoint
Efficacy of early continuous of HSS
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Hypertonic Saline Solution

Experimental

Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)

Intervention: Hypertonic saline solution (Drug)

Standard

No Intervention

Standard of care

Outcomes

Primary Outcomes

Efficacy of early continuous of HSS

Time Frame: 6 months

Rate of moderate to no dependency in activities in daily living at 6 months is defined as a Barthel Index of independence in activities in daily living ≥ 61.

Efficacy of early continuous of HSS

Time Frame: 3 months

Survival : number of patients still alive

Secondary Outcomes

  • Quality of life(until 12 months)
  • Neurological recovery(until 12 months)
  • Anterograde amnesia(until 6 months)
  • Neurocognitive functioning(6 months)
  • Cost-effectiveness analysis(12 months)
  • Neurological outcome(6 months)
  • Genetic biomarkers(12 months)
  • Treatment of intracranial hypertension(7 days)
  • Tolerance(1 month)
  • Neurological recovery(7 days)
  • Quality of life(until 12 month)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (40)

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