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

  • Figure 2
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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 Nov 2021, svn-2021-001070; 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 Nov 2021, svn-2021-001070; 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 Nov 2021, svn-2021-001070; DOI: 10.1136/svn-2021-001070
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