Chandra 1978.
Methods | Single centre study Random allocation (method of randomisation not described) Double‐blind treatment ITT analysis |
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Participants | Clinical diagnosis of aneurysmal SAH confirmed in CSF and on angiography Male:female: treatment group 11:9; placebo group 10:9 Mean age 51 years (range 20 to 65) Excluded: SAH > 7 days, 'relevant associated illness' |
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Interventions | Tranexamic acid (6 g per day iv in 6 doses) versus identical‐appearing placebo treatment for a treatment duration of 3 weeks No report on surgical interventions |
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Outcomes | Outcome: deaths from all causes at 3‐week follow‐up Events: rebleeding: reported, not defined; cerebral ischaemia: not reported; hydrocephalus: not reported | |
Notes | No report on how many rebleeding were established on CT scan or at necropsy | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | In the text, participants were reported to be randomly allocated, but how this was achieved is not reported |
Allocation concealment (selection bias) | Low risk | Identical medication; however, unclear how medication was coded |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Neither the investigators nor the patients knew which subjects received which substance" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described in text |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
Selective reporting (reporting bias) | Unclear risk | Unclear |
Other bias | Unclear risk | More male than female participants included, which could point to some form of bias since people with SAH are more often female |