Tsementzis 1990.
| Methods | Single‐centre study Random allocation (identical sequentially numbered medication boxes) Double‐blind treatment Not strictly ITT: 4 participants excluded after randomisation who missed a few doses medication | |
| Participants | Clinical diagnosis of aneurysmal SAH verified on CT or in the CSF Male:female: treatment group 20:30; placebo group 26:24 Age distribution similar in both groups Excluded: SAH > 72 hours, antihypertensives or medication known to affect the fibrinolytic or coagulation systems, acute myocardial infarction, coagulation disorders or thrombotic disease, renal failure, pregnancy, previous tranexamic acid‐treatment or people in whom death seemed imminent | |
| Interventions | Tranexamic acid (9 g per day, iv in 6 doses in week 1, orally in 4 doses in week 2, 3 and 4) versus identical‐appearing placebo treatment for a maximum treatment duration of 4 weeks# Treatment was discontinued if an operation for the aneurysm began or if deep vein thrombosis or pulmonary infarction developed |
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| Outcomes | Outcome: Glasgow Outcome Scale at discharge, 1, 3 and 6 months Events: rebleeding: reported and defined ‐ 'clinical signs confirmed on CT, in the CSF or at necropsy'; ischaemia: reported and defined ‐ 'clinical signs combined with the absence of evidence of rebleeding on CT or CSF'; hydrocephalus: reported, not defined | |
| Notes | No report of how many participants' rebleedings or cerebral ischaemia were established on CT scan or at necropsy No definition on hydrocephalus other then 'ventricular dilatation was seen on angiography' | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation was not described |
| Allocation concealment (selection bias) | Low risk | Placebo controlled trial with sequentially numbered boxes with trial medication was used |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Boxes with either tranexamic acid or placebo were used that were numbered consecutively by the pharmacist |
| 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 | 4 participants were excluded and no mention is made on their outcome |
| Selective reporting (reporting bias) | Unclear risk | Not reported in the text |
| Other bias | Unclear risk | 20 participants with protocol violations were excluded from the analysis after randomisation |