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Recruiting NCT07319208

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

Phase III Interventional TBI Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypertonic saline solution.
Who it may be relevant to
Registry conditions: TBI Traumatic Brain Injury. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

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

Primary outcome measures

  • Efficacy of early continuous of HSS [Time frame: 3 months]
  • Efficacy of early continuous of HSS [Time frame: 6 months]
Secondary outcome measures (12)
  • Treatment of intracranial hypertension [Time frame: 7 days]
  • Treatment of intracranial hypertension [Time frame: 7 days]
  • Treatment of intracranial hypertension [Time frame: 7 days]
  • Neurological recovery [Time frame: 7 days]
  • Neurological recovery [Time frame: until 12 months]
  • Quality of life [Time frame: until 12 month]
  • Quality of life [Time frame: until 12 months]
  • Anterograde amnesia [Time frame: until 6 months]
  • Neurocognitive functioning [Time frame: 6 months]
  • Neurological outcome [Time frame: 6 months]
  • Tolerance [Time frame: 1 month]
  • Tolerance [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

France · 23 centers
  • CHU d'Angers — Angers
  • CHU de Brest — Brest
  • CHU Caen Normandie — Caen
  • CHU de Clermont- Ferrand — Clermont-Ferrand
  • Hôpital BEAUJON APHP — Clichy
  • CHU Henri Mondor APHP — Créteil
  • CH de Annecy Genevois — Épagny
  • CHU de Grenoble — Grenoble
  • … and 15 more centers

Identifiers

NCT: NCT07319208 · RC24_0543 · 2024-520205-39-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗