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. 2013 Aug 30;2013(8):CD001245. doi: 10.1002/14651858.CD001245.pub2

Hillman 2002.

Methods Multi‐centre study
 Random allocation (sequence generation not specified) with sealed envelopes (not specified if opaque or not)
 No blind treatment
 Not strictly ITT: 91 participants excluded after randomisation because no aneurysm was found
Participants People suffering from CT‐verified SAH within 48 hours prior to hospital admission
 Male:female ratio: 1.89 in both groups
 Age distribution similar in both groups
 Excluded: SAH > 48 hours, age < 15 years, pregnancy, and history of thromboembolic disease. People in whom no aneurysm was demonstrated on angiographic studies were excluded after randomisation
Interventions Tranexamic acid (1 g iv immediately before transport, 1 g iv after 2 hours, and then 1 g every 6th hour until aneurysm occlusion up to 72 hours after SAH) versus control treatment
Outcomes Outcome: Glasgow Outcome Scale at 6 months
Events: rebleeding confirmed on CT or during operation until 72 hours after admission; clinically established delayed ischaemic neurological deficit at 6 months, not confirmed by imaging
Notes Poor description of delayed ischaemic neurological deficit and how this was scored
 No mention of follow‐up for rebleeding after 72 hours
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Sequence generation was not described in the text
Allocation concealment (selection bias) Unclear risk Sealed envelopes were used that contained a randomisation document; however, it was not reported how these were ordered and if they were opaque or not
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and personnel were not blinded (open study)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not described in the text
Incomplete outcome data (attrition bias) 
 All outcomes High risk 15% of included participants not evaluated in final analysis, which might have resulted in an overestimation of the effect estimate
Selective reporting (reporting bias) Unclear risk Previously published protocol was not mentioned, clinical outcome reported although not described in introduction or methods
Other bias Low risk None suspected based on study design and outcome