| Methods |
Single‐centre study
Random allocation (identical sequentially numbered sealed envelope)
No blind treatment
Not strictly ITT: 1 of the 30 control participants was excluded after randomisation because he had received tranexamic acid before admission |
| Participants |
Clinical diagnosis of aneurysmal SAH verified with CSF, CT scan and angiography
Male:female: treatment group 13:17; control group 12:17
Mean age: treatment group 50 years (range 19 to 72); control group 53 years (range 27 to 70)
Excluded: SAH > 3 days and known thrombotic disease |
| Interventions |
Tranexamic acid (6 g per day iv in 6 doses during the first week, 4 g in 4 doses iv in week 2 and 6 g orally in 4 doses in week 3 to 6) for a maximum duration of 6 weeks versus control group. Treatment continued until rebleeding, operation, discharge or death |
| Outcomes |
Outcome: deaths from all causes at 6‐week follow‐up
Events: rebleeding: reported, confirmed by CSF examination/spectrophotometry, CT‐scan or at necropsy; cerebral ischaemia: reported, not defined; hydrocephalus: reported, not defined |
| Notes |
Of the participants with rebleeding, 5 of 6 in the treatment group and 5 of 7 in the control group died. All had necropsy. In the remaining participants rebleeding was confirmed by CT. 6 of 8 participants with cerebral ischaemia in the treatment group and 2 of 3 in the control group died. All had necropsy, in the remaining participants cerebral ischaemia was established on CT |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described in the text |
| Allocation concealment (selection bias) |
Unclear risk |
"Patients were assigned randomly" and "the sealed envelope technique was used"
It was not mentioned whether these envelopes 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 |
High risk |
Part of recurrent haemorrhages were confirmed by lumbar puncture |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
1 participant was excluded from final analysis |
| Selective reporting (reporting bias) |
Low risk |
Protocol was previously published |
| Other bias |
Low risk |
None suspected based on study design and outcome |
