Van Rossum 1977.
| Methods | Multicentre study Random allocation ("drug or placebo randomly administered in a sequence prescribed by and only known to the statistician") Double‐blind treatment Not strictly ITT: 3 participants excluded, because of other diagnosis, after randomisation |
|
| Participants | Clinical diagnosis of aneurysmal SAH verified in the CSF Male:female ratio or age distribution not described Excluded: SAH > 14 days (in 94% of the participants, treatment started within 1 week) | |
| Interventions | Tranexamic acid (4 g per day iv in 4 doses) versus identically appearing placebo treatment for a maximum treatment duration of 10 days Treatment was discontinued after the aneurysm operation | |
| Outcomes | Outcome: all‐cause mortality at 3 months Events: rebleeding: reported and defined ‐ 'clinical signs confirmed in the CSF or at necropsy'; ischaemia: not reported; hydrocephalus: not reported | |
| Notes | Rebleeds 'confirmed' by CSF examination are not useable (see text), not reported how many rebleedings were established on CT scan or at necropsy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sequence was generated by an independent statistician |
| Allocation concealment (selection bias) | Low risk | Sequence was only known to the statistician and "it was impossible for medical staff or patients to distinguish between drug‐ and placebo‐containing ampoules" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "It was impossible for medical staff or patients to distinguish between drug‐ and placebo‐containing ampoules" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported in the text, but because of control with placebo not thought to have influenced results |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 3 participants were excluded and not mentioned further |
| Selective reporting (reporting bias) | Low risk | Protocol was previously published |
| Other bias | Low risk | None suspected based on study design and outcome |