Traumatic brain injury Injury, Occupational Diseases, Poisoning Traumatic brain injury
Conditions
Interventions
Time:
HITS-NS is not studying a new patient intervention, the new technology under scrutiny is the timing of neurosurgery in patients who are injured nearest an acute hospital emergency department, ve
the other interventions will be less frequent. The time to each of these interventions will be recorded, the time to ABC stabilisation will be from time zero to whichever ABC intervention procedure is
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients injured nearest an acute general hospital Emergency Department (AHED) but not more than one hour land ambulance journey from a neuroscience centre (NC) thought to be aged greater than 15 years, when assessed at scene by ambulance personnel with both: 1. Signs of significant TBI such as a reduced conscious level (GCS less than 13) and external signs of head injury, and 2. No overt signs of airway, breathing and circulation compromise
Exclusion criteria
Exclusion criteria: Patients who fulfil ANY of the following criteria will be excluded: 1. Thought to be aged less than 16 years 2. Have been found by the treating paramedic to not have signs of traumatic brain injury at the scene (i.e. full or only mildly impaired consciousness GCS greater than 12) 3. Who have obvious life threatening injuries affecting the airway, breathing or circulation: A. Partial or complete airway obstruction/contamination present after simple manoeuvres B. Respiratory rate less than 12 or greater than 30, or sucking chest wound or signs of tension pneumothorax such as absent air entry into a hemithorax with contralateral tracheal deviation C. Significant external haemorrhage not easily controlled by pressure, or amputation above the wrist or ankle or absence of radial pulse on palpation (Paramedics recognise these signs as part of their current scope of practice) 4. Who are injured more than an hour's travelling time from a neuroscience centre
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Six-month Extended Glasgow Outcome Scale 2. EQ-5D scores 3. 30-day mortality | — |
Primary
| Measure | Time frame |
|---|---|
| 1. The actual versus required recruitment rate to HITS NS for each ambulance service (AS). For the study to be considered feasible the monthly recruitment rate should be at least 50% of that required and increasing at 12 months. The recruitment rate should also be equivalent within control and intervention clusters within each AS. Recruitment will depend on early patient identification by the research paramedics from patient report forms then later obtaining patient / next of kin consent to follow up. The required rate is determined by the power calculation and current incident rate of TBI presenting to each AS. 2. The degree of selection bias caused by non - compliance with HITS-NS randomisation for each AS. For further study to be considered feasible there should be no significant difference between the characteristics of patients in groups where randomisation is and is not complied with. This should be true overall and within each trial arm. These characteristics include absolute patient transportation times from the nearest AHED and neurosurgical hospitals, and the increase in transportation time involved in bypassing nearest AHED. There should also be equivalence of factors determining survival and disability after TBI including age, Injury Severity Score (ISS), scene vital signs, pupillary responses and severity of TBI. 3. Rate of compliance with trial randomisation for each AS. For further study to be considered feasible the non compliance rate should not exceed 10% (in each arm) 4. Rates of acceptability of control and intervention pathways to patients, staff and families. For a full trial to be feasible there should be no significant difference between trial arms. This will be assessed by questionnaires and incident reporting. 5. Rates of actual TBI in patients recruited to the trial. For further study to be considered feasible this should exceed 80% in each AS and be equivalent between trial arms. | — |
Countries
United Kingdom
Outcome results
None listed