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Clinical Randomisation of an Anti-fibrinolytic in Symptomatic mild Head injury in older adults

Intramuscular tranexamic acid for the treatment of symptomatic mild traumatic brain injury in older adults: a randomised, double-blind, placebo-controlled trial

Guide to enrollment

First decide if the patient is eligible:

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:


Step by Step Guide to Recruitment:

In normal working hours:
Out of hours and weekends:
  1. Collect paperwork from magazine rack in ambulance bay near the automatic doors
  2. ambulance bay document rack
  3. Consent Patient (or obtain from family member or an uninvolved Dr who can act as Professional Representative if patient lacks capacity) and provide Patient Information Sheet
  4. Obtain syringe pack from the Research cupboard in Area B – take the next pack in numerical order (key to unlock cupboard is with the resus room nurse in charge)
  5. Drug cupboard location
  6. Find a Dr able to prescribe (see link)
  7. Place order using “CRASH4” and type in trial pack number from the above pack (xxxx/xxx)
  8. Administer IM injection to patient (either 1x5ml or 2x 2.5ml), give them the wristband, sign on MAR (including counter-sign)
  9. Document in EPIC using smartphrase .CRASH4
  10. Complete paper ENTRY FORM in paperwork pack
  11. Place ALL paperwork in the research letterbox (on the wall behind the receptionists)
  12. Send ED Research Team an EPIC chat message with patient details - it'll be picked up the following shift

Link for further information:

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