Prevention of haematoma progression by tranexamic acid in intracerebral haemorrhage patients with and without spot sign on admission scan: a statistical analysis plan of a pre-specified sub-study of the TICH-2 trial

Research output: Contribution to journalJournal articleResearchpeer-review

  • Christian Ovesen
  • Janus Christian Jakobsen
  • Christian Gluud
  • Steiner, Thorsten
  • Zhe Law
  • Katie Flaherty
  • Rob A Dineen
  • Philip M Bath
  • Nikola Sprigg
  • Hanne Christensen

OBJECTIVE: We present the statistical analysis plan of a prespecified Tranexamic Acid for Hyperacute Primary Intracerebral Haemorrhage (TICH)-2 sub-study aiming to investigate, if tranexamic acid has a different effect in intracerebral haemorrhage patients with the spot sign on admission compared to spot sign negative patients. The TICH-2 trial recruited above 2000 participants with intracerebral haemorrhage arriving in hospital within 8 h after symptom onset. They were included irrespective of radiological signs of on-going haematoma expansion. Participants were randomised to tranexamic acid versus matching placebo. In this subgroup analysis, we will include all participants in TICH-2 with a computed tomography angiography on admission allowing adjudication of the participants' spot sign status.

RESULTS: Primary outcome will be the ability of tranexamic acid to limit absolute haematoma volume on computed tomography at 24 h (± 12 h) after randomisation among spot sign positive and spot sign negative participants, respectively. Within all outcome measures, the effect of tranexamic acid in spot sign positive/negative participants will be compared using tests of interaction. This sub-study will investigate the important clinical hypothesis that spot sign positive patients might benefit more from administration of tranexamic acid compared to spot sign negative patients. Trial registration ISRCTN93732214 ( ).

Original languageEnglish
Article number379
JournalBMC Research Notes
Issue number1
Pages (from-to)1-8
Number of pages8
Publication statusPublished - 2018

    Research areas

  • Antifibrinolytic Agents/administration & dosage, Cerebral Hemorrhage/diagnostic imaging, Data Interpretation, Statistical, Disease Progression, Hematoma/diagnostic imaging, Humans, Outcome Assessment (Health Care)/statistics & numerical data, Tranexamic Acid/administration & dosage

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