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Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT

Sprigg N 1 , Flaherty K 1 , Appleton JP 1 , Al-Shahi Salman R 2 , Bereczki D 3 , Beridze M 4 Show all authors , Ciccone A 5 , Collins R 6 , Dineen RA 7 , Duley L 8 , Egea-Guerrero JJ 9 , England TJ 10 , Karlinski M 11 , Krishnan K 1 , Laska AC 12 , Law ZK 1 , Ovesen C 13 , Ozturk S 14 , Pocock SJ 15 , Roberts I 16 , Robinson TG 17 , Roffe C 18 , Peters N 19 , Scutt P 1 , Thanabalan J 20 , Werring D 21 , Whynes D 22 , Woodhouse L 1 , Bath PM 1

Affiliations 

  • 1 Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
  • 2 Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
  • 3 Department of Neurology, Semmelweis University, Budapest, Hungary
  • 4 The First University Clinic of Tbilisi State Medical University, Tbilisi, Georgia
  • 5 Neurology Unit, Azienda Socio Sanitaria Territoriale di Mantova, Mantua, Italy
  • 6 Stroke Service, Adelaide and Meath Hospital, Tallaght, Ireland
  • 7 Radiological Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK
  • 8 Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
  • 9 UGC de Medicina Intensiva, Hospital Universitario Virgen del Rocío, IBiS/CSIC/Universidad de Sevilla, Seville, Spain
  • 10 Vascular Medicine, Division of Medical Sciences & GEM, University of Nottingham, Derby, UK
  • 11 Second Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland
  • 12 Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden
  • 13 Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Department of Neurology, Copenhagen, Denmark
  • 14 Department of Neurology, Selcuk University Medical Faculty, Konya, Turkey
  • 15 Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK
  • 16 Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK
  • 17 Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK
  • 18 Stroke Research, Faculty of Medicine and Health Sciences, Keele University, Keele, UK
  • 19 Department of Neurology and Stroke Center, University Hospital Basel, Basel, Switzerland
  • 20 Division of Neurosurgery, Department of Surgery, National University of Malaysia, Kuala Lumpur, Malaysia
  • 21 Stroke Research Centre, University College London Queen Square Institute of Neurology, Faculty of Brain Sciences of University College London, University College London, London, UK
  • 22 School of Economics, University of Nottingham, Nottingham, UK
Health Technol Assess, 2019 07;23(35):1-48.
PMID: 31322116 DOI: 10.3310/hta23350

Abstract

BACKGROUND: Tranexamic acid reduces death due to bleeding after trauma and postpartum haemorrhage.

OBJECTIVE: The aim of the study was to assess if tranexamic acid is safe, reduces haematoma expansion and improves outcomes in adults with spontaneous intracerebral haemorrhage (ICH).

DESIGN: The TICH-2 (Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage) study was a pragmatic, Phase III, prospective, double-blind, randomised placebo-controlled trial.

SETTING: Acute stroke services at 124 hospitals in 12 countries (Denmark, Georgia, Hungary, Ireland, Italy, Malaysia, Poland, Spain, Sweden, Switzerland, Turkey and the UK).

PARTICIPANTS: Adult patients (aged ≥ 18 years) with ICH within 8 hours of onset.

EXCLUSION CRITERIA: Exclusion criteria were ICH secondary to anticoagulation, thrombolysis, trauma or a known underlying structural abnormality; patients for whom tranexamic acid was thought to be contraindicated; prestroke dependence (i.e. patients with a modified Rankin Scale [mRS] score > 4); life expectancy  4.5 hours after stroke onset. Pragmatic inclusion criteria led to a heterogeneous population of participants, some of whom had very large strokes. Although 12 countries enrolled participants, the majority (82.1%) were from the UK.

CONCLUSIONS: Tranexamic acid did not affect a patient's functional status at 90 days after ICH, despite there being significant modest reductions in early death (by 7 days), haematoma expansion and SAEs, which is consistent with an antifibrinolytic effect. Tranexamic acid was safe, with no increase in thromboembolic events.

FUTURE WORK: Future work should focus on enrolling and treating patients early after stroke and identify which participants are most likely to benefit from haemostatic therapy. Large randomised trials are needed.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN93732214.

FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 35. See the NIHR Journals Library website for further project information. The project was also funded by the Pragmatic Trials, UK, funding call and the Swiss Heart Foundation in Switzerland.

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

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