ULTRA Trial4

  • Published in the Lancet in Jan 2021, this study aimed to investigate whether ultra-early, short-term treatment with TXA after subarachnoid haemorrhage improves clinical outcome at 6 months.
  • It was a randomised, controlled, open-label trial with masked outcome assessment in eight treatment centres and 16 referring hospitals in the Netherlands.
  • Adult patients with spontaneous CT-proven subarachnoid haemorrhage were randomly assigned to treatment with TXA in addition to care as usual (TXA group) or care as usual only (control group).
  • TXA was started immediately after diagnosis in the presenting hospital (1 g bolus, followed by continuous infusion of 1 g every 8 h, terminated immediately before aneurysm treatment, or 24 h after start of the medication, whichever came first).
  • 955 patients were enrolled; 480 patients were assigned to TXA and 475 patients to the control group.
  • In the intention-to-treat analysis, good clinical outcome a modified Rankin scale 0-3 was observed in 287 (60%) of 475 patients in the TXA group, and 300 (64%) of 470 patients in the control group (treatment centre adjusted odds ratio 0·86, 95% CI 0·66-1·12).
  • Rebleeding after randomisation and before aneurysm treatment occurred in 49 (10%) patients in the TXA and in 66 (14%) patients in the control group (odds ratio 0·71, 95% CI 0·48-1·04). Other serious adverse events were comparable between groups.
  • In patients with CT-proven subarachnoid haemorrhage, presumed to have been caused by a ruptured aneurysm, ultra-early, short-term tranexamic acid treatment did not improve clinical outcome at 6 months, as measured by the modified Rankin Scale.