Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC)
Keith W Muir,
Gary Ford,
Philip M Bath,
Adnan I Qureshi,
Thompson G Robinson,
Rustam Al-Shahi Salman,
Hisatomi Arima,
Lisa J Woodhouse,
Eivind Berge,
Nikola Sprigg,
Xia Wang,
Tom J Moullaali,
Zhe Kang Law,
Candice Delcourt,
Kailash Krishnan,
Else C Sandset,
Craig S Anderson,
Yuko Palesch,
John Potter,
Jeff Saver,
Nerses Sanossian,
Ken Butcher,
Kennedy R Lees,
Janneke Horn
Affiliations
Keith W Muir
School of Psychology and Neuroscience, University of Glasgow, Glasgow, UK
Gary Ford
5Health Science Networks, Oxford University Hospitals, UK
Philip M Bath
4 Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, Nottinghamshire, UK
Adnan I Qureshi
3 Zeenat Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA
Thompson G Robinson
1Cerebral Haemodynamics in Ageing and Stroke Medicine (CHiASM) Research Group, Department of Cardiovascular Sciences, University of Leicester, UK
Rustam Al-Shahi Salman
3 Edinburgh Clinical Trials Unit, The University of Edinburgh, Edinburgh, UK
Hisatomi Arima
Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
Lisa J Woodhouse
1 Stroke, Division of Clinical Neurosciences, University of Nottingham, Nottingham, UK
Eivind Berge
4 Department of Internal Medicine and Cardiology, Oslo University Hospital, Oslo, Norway
Nikola Sprigg
1 Stroke, Division of Clinical Neurosciences, University of Nottingham, Nottingham, UK
Xia Wang
Department of Rheumatology, Royal North Shore Hospital, Northern Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Tom J Moullaali
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
Zhe Kang Law
Stroke Trials Unit, Mental Health and Clinical Neurosciences, University of Nottingham, Nottingham, UK
Candice Delcourt
Department of Clinical Medicine, Faculty of Medicine, Health and Human Sciences, Macquarie University, Sydney, New South Wales, Australia
Kailash Krishnan
Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK
Else C Sandset
Department of Neurology, Oslo University Hospital, Oslo, Norway
Craig S Anderson
Global Brain Health Program, The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Yuko Palesch
John Potter
Stroke Research Group, Norfolk and Norwich University Hospital, UK
Jeff Saver
Nerses Sanossian
Ken Butcher
Department of Neurology, Liverpool Hospital, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia
Kennedy R Lees
professor of cerebrovascular medicine
Janneke Horn
Amsterdam Neuroscience - Brain Imaging, Amsterdam, The Netherlands
Introduction Conflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.Methods and analysis A systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient’s demographic, clinical and prestroke neuroradiological characteristics.Ethics and dissemination No new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.PROSPERO registration number CRD42019141136.
