Eligibility
Local study conflicts
- None
Inclusion Criteria:
- Aged 50yrs or over
- History or evidence of HI (for example: laceration; bruising; swelling or pain in head or face)
- GCS – 13, 14 or 15
- Has had one or more of:
- LOC &/or Amnesia &/or Confusion &/o Drowsy
- Nausea and/or Vomiting
- Within 3hrs of injury
Exclusion Criteria:
- Lives in nursing home, mental health institution or prison
- Over 3hrs since injury or time unknown
- TXA is clearly indicated due to other injuries, or contraindicated
If the patient is eligible:
- Gain verbal agreement in principle before proceeding. Inform the patient:
- That they may be eligible for a research study
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition
- If they change their mind they can withdraw their participation at any point
Step by Step Guide to Recruitment:
In standard working hours
- The team aims to be available 8am-4pm Monday to Friday; but this is variable. Please check alertive/phone to enquire whether team member is available
- Contact them via Ed research on alertive or extension 1041.
When the ED Research team is not available:
Estimated time required:
- 30 minutes
Gather documentation
- All relevant documentation is on the shelves in trolley bay, opposite 5. Each pack contains all required paperwork.
Eligibility confirmation
- Eligibility must be confirmed by a registered professional on the delegation log.
- A list of who is on the delegation log is with the flow-coordinators.
- Contact the EM Consultant in Charge for support if need be
- Complete the eligibility section of entry form
Formal consent process
- Only clinicians on the delegation log can consent a patient
- Provide the patient with the Patient Information Sheet (PIS) and consent sheets
- Paper consent is used. The consent form is in the recruitment pack.
- A personal legal representative can be used if patient lacks capacity and a family member is available.
- Alternatively, if no family member is available, a professional legal representative can be used. Consultants who are not involved in the study are able to do this.
Randomisation procedure
- Drug packs are kept in the designated research cupboard behind the trolley bay coordinator.
- The drug packs contain either IMP or placebo in random order. Please take them in number order.
- The key to this cupboard is in the key safe in the clean prep room in trolley bay - the code to this cupboard has only been made available to those appropriately trained and on the delegation log.
Carrying out the intervention(s):
- Prescribe and administer CRASH 4 trial drug (see EMPA instructions in pack )
- The CRASH 4 drug is given intramuscularly (all relevant equipment is in the drug pack). It can be given in 1 or 2 sites.
- Continuation paperwork is provided in the recruitment pack with the relevant stickers on.
Completed documents (if relevant)
- Document on continuation sheets using the stickers provided.
- Complete the entry form and patient detail form
- Ensure you have given the patient a copy of their consent form, PIS and drug alert card.
- Email EMresearch@nnuh.nhs.uk to inform them of recruitment
Disposition and follow-up:
If admitted:
- Any documentation on continuation paper needs to go with the patient to the ward.
- Please place the data entry form and any unused paperwork to be placed on the research desk in CHED
- Place the orange wrist band (found inside the drug pack) on the patient.
If discharged:
- Give standard head injury advice.
- Please place all paperwork on the research desk in CHED
Inform the research team of the patient you've recruited
- Email EMresearch@nnuh.nhs.uk to inform them of recruitment