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

Sprigg, Nikola; Flaherty, Katie; Appleton, Jason P; Al-Shahi Salman, Rustam; Bereczki, Daniel; Beridze, Maia; Ciccone, Alfonso; Collins, Ronan; Dineen, Robert A; Duley, Lelia; Egea-Guerrero, Juan José; England, Timothy J; Karlinski, Michal; Krishnan, Kailash; Laska, Ann Charlotte; Law, Zhe Kang; Ovesen, Christian; Ozturk, Serefnur; Pocock, Stuart J; Roberts, Ian; Robinson, Thompson G; Roffe, Christine; Peters, Nils; Scutt, Polly; Thanabalan, Jegan; Werring, David; Whynes, David; Woodhouse, Lisa; Bath, Philip M

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

Citation

Sprigg, N., Flaherty, K., Appleton, J. P., Al-Shahi Salman, R., Bereczki, D., Beridze, M., Ciccone, A., Collins, R., Dineen, R. A., Duley, L., Egea-Guerrero, J. J., England, T. J., Karlinski, M., Krishnan, K., Laska, A. C., Law, Z. K., Ovesen, C., Ozturk, S., Pocock, S. J., Roberts, I., …Bath, P. M. (2019). Tranexamic acid to improve functional status in adults with spontaneous intracerebral haemorrhage: the TICH-2 RCT. Health Technology Assessment, 23(35), 1-48. https://doi.org/10.3310/hta23350

• Journal Article Type: Article
• Acceptance Date: Mar 21, 2019
• Publication Date: Jul 1, 2019
• Deposit Date: Aug 12, 2019
• Publicly Available Date: Aug 12, 2019
• Journal: Health Technology Assessment
• Print ISSN: 1366-5278
• Electronic ISSN: 2046-4924
• Publisher: NIHR Journals Library
• Peer Reviewed: Peer Reviewed
• Volume: 23
• Issue: 35
• Pages: 1-48
• DOI: https://doi.org/10.3310/hta23350
• Keywords: Health Policy
• Public URL: https://nottingham-repository.worktribe.com/output/2417671
• Publisher URL: https://www.journalslibrary.nihr.ac.uk/hta/hta23350#/abstract
• Contract Date: Aug 12, 2019