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Effects of blood pressure and tranexamic acid in spontaneous intracerebral haemorrhage: a secondary analysis of a large randomised controlled trial

Appleton JP 1 , Law ZK 2 , Woodhouse LJ 2 , Al-Shahi Salman R 3 , Beridze M 4 , Christensen H 5 Show all authors , Dineen RA 6 , Guerrero JJE 7 , England TJ 2 , Karlinski M 8 , Krishnan K 1 , Laska AC 9 , Lyrer P 10 , Ozturk S 11 , Roffe C 12 , Roberts I 13 , Robinson TG 14 , Scutt P 2 , Werring DJ 15 , Bath PM 1 , Sprigg N 1

Affiliations 

  • 1 Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK
  • 2 Stroke Trials Unit, Mental Health and Clinical Neurosciences, University of Nottingham, Nottingham, UK
  • 3 Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
  • 4 The First University Clinic, Tbilisi State Medical University, Tbilisi, Georgia
  • 5 Department of Neurology, Copenhagen University Hospital, Bispebjerg, Denmark
  • 6 Radiological Sciences, Mental Health and Clinical Neurosciences, University of Nottingham, Nottingham, UK
  • 7 Neurocritical Care Unit, Virgen del Rocio University Hospital, Sevilla, Spain
  • 8 2nd Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland
  • 9 Department of Clinical Sciences, Danderyd Hospital, Karolinska Institute, Stockholm, Sweden
  • 10 Neurology and Stroke Center, University Hospital Basel, Basel, Switzerland
  • 11 Neurology, Faculty of Medicine, Selcuk Universitesi, Konya, Turkey
  • 12 Stroke Research, School of Medicine, University of Keele, Stoke-on-Trent, UK
  • 13 Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK
  • 14 College of Life Sciences, University of Leicester, Leicester, UK
  • 15 Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, London, UK
BMJ Neurol Open, 2023;5(1):e000423.
PMID: 37337529 DOI: 10.1136/bmjno-2023-000423

Abstract

BACKGROUND: Tranexamic acid reduced haematoma expansion and early death, but did not improve functional outcome in the tranexamic acid for hyperacute spontaneous intracerebral haemorrhage-2 (TICH-2) trial. In a predefined subgroup, there was a statistically significant interaction between prerandomisation baseline systolic blood pressure (SBP) and the effect of tranexamic acid on functional outcome (p=0.019).

METHODS: TICH-2 was an international prospective double-blind placebo-controlled randomised trial evaluating intravenous tranexamic acid in patients with acute spontaneous intracerebral haemorrhage (ICH). Prerandomisation baseline SBP was split into predefined ≤170 and >170 mm Hg groups. The primary outcome at day 90 was the modified Rankin Scale (mRS), a measure of dependency, analysed using ordinal logistic regression. Haematoma expansion was defined as an increase in haematoma volume of >33% or >6 mL from baseline to 24 hours. Data are OR or common OR (cOR) with 95% CIs, with significance at p<0.05.

RESULTS: Of 2325 participants in TICH-2, 1152 had baseline SBP≤170 mm Hg and were older, had larger lobar haematomas and were randomised later than 1173 with baseline SBP>170 mm Hg. Tranexamic acid was associated with a favourable shift in mRS at day 90 in those with baseline SBP≤170 mm Hg (cOR 0.73, 95% CI 0.59 to 0.91, p=0.005), but not in those with baseline SBP>170 mm Hg (cOR 1.05, 95% CI 0.85 to 1.30, p=0.63). In those with baseline SBP≤170 mm Hg, tranexamic acid reduced haematoma expansion (OR 0.62, 95% CI 0.47 to 0.82, p=0.001), but not in those with baseline SBP>170 mm Hg (OR 1.02, 95% CI 0.77 to 1.35, p=0.90).

CONCLUSIONS: Tranexamic acid was associated with improved clinical and radiological outcomes in ICH patients with baseline SBP≤170 mm Hg. Further research is needed to establish whether certain subgroups may benefit from tranexamic acid in acute ICH.

TRIAL REGISTRATION NUMBER: ISRCTN93732214.

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

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