Affiliations 

  • 1 Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg bakke 23, 2400, Copenhagen, Denmark. Christian.aavang.ovesen@regionh.dk
  • 2 The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  • 3 Department of Neurology, Klinikum Frankfurt Höchst, Frankfurt, Germany
  • 4 Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, City Hospital Campus, Nottingham, NG5 1PB, UK
  • 5 Radiological Sciences, Division of Clinical Neuroscience, Queen's Medical Centre, University of Nottingham, Nottingham, NG7 2UH, UK
  • 6 Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg bakke 23, 2400, Copenhagen, Denmark
BMC Res Notes, 2018 Jun 13;11(1):379.
PMID: 29895329 DOI: 10.1186/s13104-018-3481-8

Abstract

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 ( http://www.isrctn.com ).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

Similar publications