Journal Club

Methodology Score: 4/5
Usefulness Score: 3/5

Sprigg N, et al. Lancet. 2018 May 26;391(10135):2107-2115

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  

Epi lesson

Cluster Randomized Controlled Trials 

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

Hans Rosenberg
Dr. Rosenberg is an emergency physician at the Ottawa Hospital, assistant professor at the University of Ottawa, and Director of the Digital Scholarship and Knowledge Dissemination Program.