Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/25204
Title: Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial.
Austin Authors: Meretoja, Atte;Yassi, Nawaf;Wu, Teddy Y;Churilov, Leonid ;Sibolt, Gerli;Jeng, Jiann-Shing;Kleinig, Timothy;Spratt, Neil J;Thijs, Vincent N ;Wijeratne, Tissa;Cho, Der-Yang;Shah, Darshan;Cloud, Geoffrey C;Phan, Thanh;Bladin, Christopher;Moey, Andrew;Aviv, Richard I;Barras, Christen D;Sharma, Gagan;Hsu, Chung Y;Ma, Henry;Campbell, Bruce C V;Mitchell, Peter;Yan, Bernard;Parsons, Mark W;Tiainen, Marjaana;Curtze, Sami;Strbian, Daniel;Tang, Sung-Chun;Harvey, Jackson;Levi, Christopher;Donnan, Geoffrey A ;Davis, Stephen M
Affiliation: Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia
Department of Neurology, Lyell McEwin Hospital, Adelaide, SA, Australia
Department of Neurology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia
Department of Neurology, Western Hospital, Melbourne, VIC, Australia
Department of Mathematics and Statistics, University of Melbourne, Melbourne, VIC, Australia
Neurology
Department of Neurology, Alfred Hospital, Monash University, Melbourne, VIC, Australia
Department of Clinical Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia
Department of Neurosciences, Eastern Health Medical School, Monash University, Melbourne, VIC, Australia
Ambulance Victoria, Melbourne, VIC, Australia
Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia
New Zealand Brain Research Institute, Christchurch, New Zealand..
The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia
Department of Neurology, Helsinki University Hospital, Helsinki, Finland
Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia
Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia
Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia
Sydney Partnership for Health, Education, Research and Enterprise (SPHERE), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia
Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia
School of Clinical Sciences, Monash University, Melbourne, VIC, Australia
South Australian Health and Medical Research Institute, The University of Adelaide, Adelaide, SA, Australia
Department of Neurology, Helsinki University Hospital, Helsinki, Finland
Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan
Department of Neurosurgery, China Medical University Hospital, Taichung, Taiwan
Department of Radiology, Neuroradiology Section, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada
Department of Neurology, China Medical University Hospital, Taichung, Taiwan
Department of Neurology, Helsinki University Hospital, Helsinki, Finland
Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan
Issue Date: 28-Oct-2020
metadata.dc.date: 2020-10-28
Publication information: The Lancet. Neurology 2020; online first: 28 October
Abstract: Despite intracerebral haemorrhage causing 5% of deaths worldwide, few evidence-based therapeutic strategies other than stroke unit care exist. Tranexamic acid decreases haemorrhage in conditions such as acute trauma and menorrhoea. We aimed to assess whether tranexamic acid reduces intracerebral haemorrhage growth in patients with acute intracerebral haemorrhage. We did a prospective, double-blind, randomised, placebo-controlled, investigator-led, phase 2 trial at 13 stroke centres in Australia, Finland, and Taiwan. Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography. Patients were randomly assigned (1:1) to receive either 1 g of intravenous tranexamic acid over 10 min followed by 1 g over 8 h or matching placebo, started within 4·5 h of symptom onset. Randomisation was done using a centralised web-based procedure with randomly permuted blocks of varying size. All patients, investigators, and staff involved in patient management were masked to treatment. The primary outcome was intracerebral haemorrhage growth (>33% relative or >6 mL absolute) at 24 h. The primary and safety analyses were done in the intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT01702636). Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the tranexamic acid group (n=50) or the placebo group (n=50). Median age was 71 years (IQR 57-79) and median intracerebral haemorrhage volume was 14·6 mL (7·9-32·7) at baseline. The primary outcome was not different between the two groups: 26 (52%) patients in the placebo group and 22 (44%) in the tranexamic acid group had intracerebral haemorrhage growth (odds ratio [OR] 0·72 [95% CI 0·32-1·59], p=0·41). There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications. None of the deaths was considered related to study medication. Our study does not provide evidence that tranexamic acid prevents intracerebral haemorrhage growth, although the treatment was safe with no increase in thromboembolic complications. Larger trials of tranexamic acid, with simpler recruitment methods and an earlier treatment window, are justified. National Health and Medical Research Council, Royal Melbourne Hospital Foundation.
URI: https://ahro.austin.org.au/austinjspui/handle/1/25204
DOI: 10.1016/S1474-4422(20)30369-0
PubMed URL: 33128912
Type: Journal Article
Appears in Collections:Journal articles

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