Eligibility

Local study conflicts

• None

Inclusion Criteria:

1. Aged 50yrs or over
2. History or evidence of HI (for example: laceration; bruising; swelling or pain in head or face)
3. GCS – 13, 14 or 15
4. Has had one or more of:
   • LOC &/or Amnesia &/or Confusion &/o Drowsy
   • Nausea and/or Vomiting
5. Within 3hrs of injury

Exclusion Criteria:

1. Lives in nursing home, mental health institution or prison
2. Over 3hrs since injury or time unknown
3. TXA is clearly indicated due to other injuries, or contraindicated

If the patient is eligible:

• Gain verbal agreement in principle before proceeding. Explain:
• 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; 8am - 4pm Monday to Friday

• Speak with EPIC (as they should be on the delegation log)
• OR
• Call Muni on extension 86981 or via Teams

Out of hours and weekends:

Gather documentation

1. Collect grab pack from CRASH-4 drug cupboard in the OU medication room.

Gaining formal consent

• Provide the patient, or family member, with the Patient Information Sheet (PIS) – PIS and consent forms are in the grab pack.
• Consent the patient (or obtain from family member, or an uninvolved Dr who can act as Professional Representative if the patient lacks capacity)

Carrying out the intervention:

• To prescribe:
  1. Type ‘CRASH-4’ and use the powerplan prescription only. DO NOT PRESCRIBE TRANEXAMIC ACID
  2. Type the trial pack number from the orange box in the prescription comment box

• Obtain the following items to give IM injection:
  1. 1x5ml or 2x2.5ml syringe
  2. 1x blunt red filter needle
  3. 1 or 2 green IM needle

• The treatment - (either placebo or active medication) is in the orange box. Open it and draw it up.
  1. Administer IM injection to patient (either 1x5ml or 2x 2.5ml),
  2. place orange wristband on patient wrist
  3. sign prescription
  4. give patient ALERT CARD (fill in the orange & white stickers -place 1 in alert card & grab pack)

• Complete ENTRY FORM paperwork (which is in the grab pack)
• Place ENTRY FORM & Original signed consent form back in grab pack. Leave the grab pack back in the CRASH-4 cupboard
• Document on eCare.

Disposition and follow-up:

• There is no specific study instructions on discharge on admission
• Manage as per usual care for head injured patients.

Link for further information:

https://crash4.lshtm.ac.uk/