Eligibility
Local study conflicts
Inclusion Criteria:
- Patients eligible for screening are all trauma patients of any age including children:
- Requiring treatment by the London Air Ambulance medical team (adults only)
- And/or
- Requiring admission to the Emergency Department with a full trauma team activation (adults and children)
Exclusion Criteria:
- Any patient who fulfils any of these criteria will not be considered for inclusion in the study:
- Transfers from other hospitals
- Burns >5% total body surface area
- >20 mins have lapsed since time of injury
- Deemed inappropriate for recruitment by an independent clinician (e.g. mass casualty event or futility)
If the patient is eligible:
- All participants will be recruited under an emergency waiver of consent.
Written informed consent or agreement to continue in the study will be obtained from the participant, personal consultee or professional consultee (independent clinician), after explanation of the aims, methods, benefits and potential hazards of the trial.
Step-by-Step Guide to Recruitment:
In the working hours of the research team:
- Monday-Friday 07:30 – 18:30
- Contact the EMROx research team on:
Mobile 0776818242
Tel 01865 222003
Bleep 6680
- The research team are included in the trauma and critical care alert and will attend to all calls during working hours.
- Prior to patient arrival the research nurse will discuss with the Trauma Team Leader about enrolling the patient to ACIT-II if eligible.
- If a patient lacks capacity and has no Personal Consultee, a Professional Consultee (usually an emergency medicine consultant) will be asked within 24 hours of enrolment to provide consent for the patient's continued study participation.
- Blood samples will be taken on admission within 120 minutes of injury. Then at 24hour,72hrs and 7day following a written consent to continue with the study.
- Samples will be processed and stored according to ACIT II study protocol.
- Patients will be followed up when in hospital daily until day 28, death or discharge (whichever occurs sooner). If patients remain in hospital beyond day 28, their electronic records will be periodically reviewed remotely until discharge to enable collection of any outstanding endpoint data. End of study is at 12 months after completion of EQ5D (adults) or PedsQL (paediatrics) patient questionnaire.
Out of hours and weekends:
- The study is not currently recruiting out of standard working hours
Further information
Link to the trial website