Traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Current interventions as of 10/06/2019:
A simple and secure, web-based and allocation concealed randomisation system will be used. Randomisation will be stratified by site and predicted probability of
Sponsors
University Hospitals Birmingham NHS Foundation Trust
University of Warwick
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 16 years or over 2. Admission to the ICU following traumatic brain injury 3. ICP >20 mmHg for more than 5 minutes despite stage 1 procedures 4. <10 days from initial head injury 5. Abnormal CT scan consistent with traumatic brain injury
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 21/12/2023: 1. Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours 2. Pregnancy 3. Severe hypernatraemia (Na >155 mmol/L) 4. Two or more prior doses of hyperosmolar therapy given on ICU Previous participant exclusion criteria as of 06/08/2020: 1. Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours 2. Pregnancy 3. Severe hypernatraemia (Na >155 mmol/L) Previous participant exclusion criteria from 10/06/2019 to 06/08/2020: 1. Devastating brain injury with withdrawal of treatment anticipated in the next 24 hours 2. Pregnancy 3. Severe hypernatraemia (Na >160 mmol/L) Original participant exclusion criteria: 1. Unsurvivable injuries 2. Pregnancy 3. Severe hypernatraemia (Na >160 mmol/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological outcome measured by patient/relative/clinician completion of the Extended Glasgow Outcome Scale (GOS-E) questionnaire at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intracranial pressure (ICP) control recorded continuously or at regular intervals from ICP bolt readings during the period of monitoring on ICU 2. Progression to stage 3 therapies (i.e. any use of additional treatments e.g. barbiturate coma, decompressive craniectomy, hypothermia, CSF drainage) recorded from the patient’s medical records during their ICU stay 3. Which stage 3 therapies were required, recorded from the patient’s medical notes during their ICU stay 4. Organ support requirements during ICU recorded from the patient’s medical records, or through data linkage, according to the Critical Care Minimum Data Set definitions 5. ICU length of stay obtained from hospital records and through data linkage 6. Hospital length of stay obtained from hospital records and through data linkage 7. Discharge location obtained from hospital records and through data linkage 8. Longer term neurological outcomes measured using the modified Oxford Handicap Score (mOHS) completed by the research or clinical team at hospital discharge, and the Extended Glasgow Outcome Scale (GOS-E) completed by the patient/relative/clinician at 12 months 9. Survival measured from the patient’s medical records at hospital discharge, 3 months, 6 months and 12 months 10. Health-related quality of life measured using the EQ-5D-5L at hospital discharge, 3 months, 6 months and 12 months post-TBI, completed by the patient/relative/clinician 11. Resource use collected from hospital records and through data linkage for the patient’s duration of hospital stay and up to 12 months post-TBI 12. Serious adverse events recorded from the time that the patient is randomised through and including 28 calendar days after the last administration of IMP | — |
Countries
Brazil, England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactHannah Noordali
Outcome results
None listed