Article open access publication

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

BMC Research Notes, Springer Nature, ISSN 1756-0500

Volume 11, 1, 2018

DOI:10.1186/s13104-018-3481-8, Dimensions: pub.1104554437, PMC: PMC5998558, PMID: 29895329,


Ovesen, Christian * (1) (2)
Law, Zhe (6) (7)
Dineen, Rob A (8) (9) (10)

* Corresponding author



  1. (1) Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg bakke 23, 2400, Copenhagen, Denmark
  2. (2) The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  3. (3) Holbæk Sygehus, grid.414289.2, Zealand Region
  4. (4) Klinikum Frankfurt Höchst, grid.492781.1
  5. (5) University Hospital Heidelberg, grid.5253.1
  6. (6) National University of Malaysia, grid.412113.4
  7. (7) Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, NG5 1PB, Nottingham, UK
  8. (8) NIHR Nottingham Biomedical Research Centre, NG1 5DU, Nottingham, UK
  9. (9) Radiological Sciences, Division of Clinical Neuroscience, Queen’s Medical Centre, University of Nottingham, NG7 2UH, Nottingham, UK
  10. (10) University of Nottingham, grid.4563.4


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 ( ).


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