Methodology Score: 4/5
Usefulness Score: 3/5
Question and Methods: Multicenter, double-blinded, randomized, placebo-controlled trial comparing if IV TXA vs placebo, given within 8h of spontaneous (non-traumatic) ICH onset, decreased death or dependence at 90 days.
Findings: No difference in 90d dependence or death [Ordinal OR 0·88 (0·76 to 1·03) p=0.11].
Limitations: Wide inclusion criteria, inclusion time up to 8 hours, and likely overestimation of the treatment effect.
Interpretation: More studies (larger studies) are needed to confirm or refute a clinically significant treatment effect for TXA in acute spontaneous ICH. If TXA is given, unlikely to cause any harm.
By: Dr. Alex Mungham
A cluster randomized trial is a trial in which individuals are randomized in groups (i.e. the group is randomized, not the individual); for example, all patients treated by a particular EMS service or at a particular hospital. Reasons for performing cluster randomized trials vary. Sometimes the intervention can only be administered to the group, for example an addition to the water supply; sometimes the motivation is to avoid contamination amongst health care providers; sometimes the design is simply more convenient or economical. Such trials are often appropriate when the intervention is a psychomotor task (e.g. CPR) but not when the intervention is a drug. Specific sample size and data analytic approaches are required.
By: Dr. Jeff Perry