Kaste 1979.
| Methods | Single‐centre study Random allocation (identical sequentially numbered treatment boxes) Double‐blind treatment Code broken after final evaluation ITT | |
| Participants | Clinical diagnosis of aneurysmal SAH verified in the CSF Male:female: active treatment group 16:16; placebo group 14:18 Age distribution similar in both groups Excluded: SAH > 72 hours, myocardial infarction within 6 months, unconsciousness, coagulation disorders or thrombotic disease, renal failure and pregnancy | |
| Interventions | Tranexamic acid (6 g per day iv in 6 doses) versus identical‐appearing placebo treatment for a maximum treatment duration of 3 weeks Treatment discontinued at operation |
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| Outcomes | Outcome: deaths from all causes at 3 months. Events: rebleeding: suspected when 2 of sudden deterioration of consciousness, increase of neck rigidity, headache or focal signs ‐ rebleeding verified in CSF or at necropsy; ischaemia: reported, not defined; hydrocephalus: reported, not defined | |
| Notes | No definition on cerebral ischaemia or hydrocephalus: 'vasospasm and ventricular dilatation were seen on angiography' | |
| 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) | Low risk | Tranexamic acid and placebo were prepared in identical vials and were coded; the code was only broken after final evaluation of the trial |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Tranexamic acid and placebo were prepared in identical vials and were coded; the code was only broken after final evaluation of the trial |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "The code identifying each substance was broken only after the final evaluation of all 64 patients" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data |
| Selective reporting (reporting bias) | Low risk | Protocol was previously published |
| Other bias | Unclear risk | Unconscious people not included causing the results to be less generalisable |