Verbaan 2012.
Trial name or title | Ultra‐early tranexamic acid after subarachnoid haemorrhage. A prospective, randomised, multicenter study |
Methods | Multicentre study Random allocation Open treatment with blind endpoint assessment Intention‐to‐treat |
Participants | Clinical diagnosis of aneurysmal SAH verified on CT with inclusion within 24 hours of start of symptoms Excluded: no loss of consciousness after the haemorrhage with WFNS grade 1 or 2 on admission in combination with a perimesencephalic haemorrhage; bleeding pattern on CT compatible with a traumatic SAH; treatment for deep vein thrombosis; history of blood coagulation disorder; pregnancy or breastfeeding; severe renal (serum creatinine > 150 mmol/L) or liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or gamma‐GT > 150 U/l); imminent death within 24 hours |
Interventions | Standard treatment with additional administration of 1 g tranexamic acid intravenously in 10 minutes, immediately after the diagnosis SAH, succeeded by continuous infusion of 1 g per 8 hours until a maximum of 24 hours |
Outcomes | Primary outcome: Modified Rankin Scale score dichotomised as a favourable (0 to 3) or unfavourable (4 to 6) outcome at 6 months after SAH Secondary: case fatality, cause of poor outcome, rebleeding rate, thromboembolic complications, delayed cerebral ischaemia, other complications (hydrocephalus, thromboembolic events, extracranial thrombosis or haemorrhagic complications), care cost |
Starting date | January 2013 |
Contact information | d.verbaan@amc.uva.nl |
Notes |
CT: computed tomography SAH: subarachnoid haemorrhage WFNS: World Federation of Neurological Societies