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 |