Eligibility
Local study conflicts
- None
Inclusion Criteria:
- ≥ 18 years old
- acute spontaneous intracerebral haemorrhage confirmed on brain imaging
- within 4.5 h of onset
Exclusion Criteria:
- Known indication for TXA treatment (e.g. traumatic brain injury)
- Known contra-indication for TXA treatment (e.g. active seizures)
- Patient known to be taking therapeutic anticoagulation with warfarin or low molecular weight heparin at time of enrolment. Patients taking direct oral anticoagulants can be included and are not excluded
- Massive ICH (usually when haematoma volume >60ml)
- Severe coma, Glasgow Coma Scale <5
- Decision for palliative (end of life) care
If the patient is eligible:
Gain verbal agreement in principle from the patient before proceeding (or from the patient's relatives if patient lacks capacity). 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; 9-5
- The ED Research Team and the CNS stroke nurses are alerted to all strokes via the stroke call.
Out of hours and weekends:
Eligibility
- Must be confirmed by a clinician
Gather documentation
- The working file is kept in the research cupboard at the end of majors
Formal consent process
- Provide a brief explanation. Emergency enrolment: oral consent unless the patient or relative or clinician objects
- Take full written consent from the patient if they have capacity.
- If they do not demonstrate capacity to consent, either NOK or legal representative or a clinician independent of the trial can give professional representative, and once they have recovered formal consent will be gained from the patient
Randomisation procedure
- randomisation procedure ---
- open the next available lowest-numbered treatment pack make sure to sign out
- please paste any relevant images
Carrying out the intervention(s):
- Medication to be ordered on EPMA by clinician and to be administered following instruction from the pack
- Document in Nerve Centre, answer yes on research patient and enter research team notes.
Disposition and follow-up:
All patients will be admitted:
- Ward based care as per hospital protocol with patients who has ICH
- Follow-up: on day 7, day of discharge and 180 days
After completion
- Please inform the ED research team of patients recruited out of hours (rosalyn.squire@nhs.net).