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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial

Nawaf Yassi, Henry Zhao, Leonid Churilov, Bruce C V Campbell, Teddy Wu, Henry Ma, Andrew Cheung, Timothy Kleinig, Helen Brown, Philip Choi, Jiann-Shing Jeng, Annemarei Ranta, Hao-Kuang Wang, Geoffrey C Cloud, Rohan Grimley, Darshan Shah, Neil Spratt, Der-Yang Cho, Karim Mahawish, Lauren Sanders, John Worthington, Ben Clissold, Atte Meretoja, Vignan Yogendrakumar, Mai Duy Ton, Duc Phuc Dang, Nguyen Thai My Phuong, Huy-Thang Nguyen, Chung Y Hsu, Gagan Sharma, Peter J Mitchell, Bernard Yan, Mark W Parsons, Christopher Levi, Geoffrey A Donnan, Stephen M Davis
DOI: 10.1136/svn-2021-001070 Published 27 April 2022
Nawaf Yassi
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
2 Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia
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Henry Zhao
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
3 Ambulance Victoria, Melbourne, Victoria, Australia
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Leonid Churilov
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
4 Melbourne Medical School, The University of Melbourne, Melbourne, Victoria, Australia
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Bruce C V Campbell
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
5 Stroke Division, The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia
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Teddy Wu
6 Department of Neurology, Christchurch Hospital, Christchurch, New Zealand
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Henry Ma
7 Department of Neurology, Monash Medical Centre, Monash University, Clayton, Victoria, Australia
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Andrew Cheung
8 Department of Interventional Neuroradiology, Liverpool Hospital, Liverpool, New South Wales, Australia
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Timothy Kleinig
9 Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
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Helen Brown
10 Department of Neurology, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
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Philip Choi
11 Department of Neurology, Box Hill Hospital, Eastern Health, Box Hill, Victoria, Australia
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Jiann-Shing Jeng
12 Stroke Centre and Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan
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Annemarei Ranta
13 Department of Medicine, Dunedin School of Medicine, University of Otago, Wellington, New Zealand
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Hao-Kuang Wang
14 Department of Neurosurgery, E-Da Hospital, Yanchao, Kaohsiung, Taiwan
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Geoffrey C Cloud
15 Department of Neurology, Alfred Hospital, Melbourne, Victoria, Australia
16 Department of Clinical Neuroscience, Monash University Central Clinical School, Melbourne, Victoria, Australia
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Rohan Grimley
17 Department of Medicine, Sunshine Coast University Hospital, Nambour, Queensland, Australia
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Darshan Shah
18 Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia
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Neil Spratt
19 Department of Neurology, John Hunter Hospital, The University of Newcastle, Newcastle, New South Wales, Australia
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Der-Yang Cho
20 Department of Neurosurgery, China Medical University Hospital, Taichung, Taiwan
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Karim Mahawish
21 Department of Internal Medicine, Palmerston North Hospital, Palmerston North, New Zealand
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Lauren Sanders
22 Department of Neurology, St Vincent's Hospital, Fitzroy, Victoria, Australia
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John Worthington
23 Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
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Ben Clissold
24 Department of Neurology, Geelong Hospital, Geelong, Victoria, Australia
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Atte Meretoja
25 Department of Neurology, Helsinki University Hospital, Helsinki, Finland
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Vignan Yogendrakumar
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
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Mai Duy Ton
26 Stroke Center, Bach Mai Hospital, Hanoi, Viet Nam
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Duc Phuc Dang
27 Stroke Department, 103 Military Hospital, Hanoi, Hanoi, Viet Nam
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Nguyen Thai My Phuong
28 Department of Neurology, Nguyen Tri Phuong Hospital, Ho Chi Minh City, Viet Nam
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Huy-Thang Nguyen
29 Department of Cerebrovascular Disease, 115 Hospital, Ho Chi Minh City, Viet Nam
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Chung Y Hsu
30 Department of Neurology, China Medical University, Taichung, Taiwan
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Gagan Sharma
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
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Peter J Mitchell
31 Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia
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Bernard Yan
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
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Mark W Parsons
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
32 Department of Neurology, Liverpool Hospital, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Sydney, New South Wales, Australia
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Christopher Levi
19 Department of Neurology, John Hunter Hospital, The University of Newcastle, Newcastle, New South Wales, Australia
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Geoffrey A Donnan
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
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Stephen M Davis
1 Department of Medicine and Neurology, Melbourne Brain Centre at The Royal Melbourne Hospital, The University of Melbourne, Parkville, Victoria, Australia
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    Figure 1

    Haematoma growth occurring between baseline (A, C) CT and follow-up CT (B, D) in a patient with a right basal ganglia haemorrhage. Panel C and D reflect the region of interest planimetric analysis used to measure haematoma volume (intraventricular segment measured separately).

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    Figure 2

    Key trial timepoints and activities. ICH, intracerebral haemorrhage; mRS, Modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; TXA, tranexamic acid.

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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial
Nawaf Yassi, Henry Zhao, Leonid Churilov, Bruce C V Campbell, Teddy Wu, Henry Ma, Andrew Cheung, Timothy Kleinig, Helen Brown, Philip Choi, Jiann-Shing Jeng, Annemarei Ranta, Hao-Kuang Wang, Geoffrey C Cloud, Rohan Grimley, Darshan Shah, Neil Spratt, Der-Yang Cho, Karim Mahawish, Lauren Sanders, John Worthington, Ben Clissold, Atte Meretoja, Vignan Yogendrakumar, Mai Duy Ton, Duc Phuc Dang, Nguyen Thai My Phuong, Huy-Thang Nguyen, Chung Y Hsu, Gagan Sharma, Peter J Mitchell, Bernard Yan, Mark W Parsons, Christopher Levi, Geoffrey A Donnan, Stephen M Davis
Stroke and Vascular Neurology Apr 2022, 7 (2) 158-165; DOI: 10.1136/svn-2021-001070

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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial
Nawaf Yassi, Henry Zhao, Leonid Churilov, Bruce C V Campbell, Teddy Wu, Henry Ma, Andrew Cheung, Timothy Kleinig, Helen Brown, Philip Choi, Jiann-Shing Jeng, Annemarei Ranta, Hao-Kuang Wang, Geoffrey C Cloud, Rohan Grimley, Darshan Shah, Neil Spratt, Der-Yang Cho, Karim Mahawish, Lauren Sanders, John Worthington, Ben Clissold, Atte Meretoja, Vignan Yogendrakumar, Mai Duy Ton, Duc Phuc Dang, Nguyen Thai My Phuong, Huy-Thang Nguyen, Chung Y Hsu, Gagan Sharma, Peter J Mitchell, Bernard Yan, Mark W Parsons, Christopher Levi, Geoffrey A Donnan, Stephen M Davis
Stroke and Vascular Neurology Apr 2022, 7 (2) 158-165; DOI: 10.1136/svn-2021-001070
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Tranexamic acid for intracerebral haemorrhage within 2 hours of onset: protocol of a phase II randomised placebo-controlled double-blind multicentre trial
Nawaf Yassi, Henry Zhao, Leonid Churilov, Bruce C V Campbell, Teddy Wu, Henry Ma, Andrew Cheung, Timothy Kleinig, Helen Brown, Philip Choi, Jiann-Shing Jeng, Annemarei Ranta, Hao-Kuang Wang, Geoffrey C Cloud, Rohan Grimley, Darshan Shah, Neil Spratt, Der-Yang Cho, Karim Mahawish, Lauren Sanders, John Worthington, Ben Clissold, Atte Meretoja, Vignan Yogendrakumar, Mai Duy Ton, Duc Phuc Dang, Nguyen Thai My Phuong, Huy-Thang Nguyen, Chung Y Hsu, Gagan Sharma, Peter J Mitchell, Bernard Yan, Mark W Parsons, Christopher Levi, Geoffrey A Donnan, Stephen M Davis
Stroke and Vascular Neurology Apr 2022, 7 (2) 158-165; DOI: 10.1136/svn-2021-001070
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