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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)
  1. Tom J Moullaali1,2,
  2. Xia Wang2,
  3. Lisa J Woodhouse3,
  4. Zhe Kang Law3,4,
  5. Candice Delcourt2,5,
  6. Nikola Sprigg3,6,
  7. Kailash Krishnan3,6,
  8. Thompson G Robinson7,8,
  9. Joanna M Wardlaw1,
  10. Rustam Al-Shahi Salman1,
  11. Eivind Berge9,
  12. Else C Sandset10,11,
  13. Craig S Anderson2,12,
  14. Philip M Bath3,6
  15. The BASC Investigators
    1. 1Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK
    2. 2George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
    3. 3Stroke Trials Unit, University of Nottingham, Nottingham, UK
    4. 4National University of Malaysia, Bangi, Malaysia
    5. 5Neurology Department, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
    6. 6Stroke, Nottingham University Hospitals NHS Trust, Nottingham, UK
    7. 7Department of Cardiovascular Sciences, University of Leicester, Leicester, UK
    8. 8National Institute for Health Research Leicester Biomedical Research Centre, Leicester, UK
    9. 9Department of Internal Medicine, Oslo University Hospital, Oslo, Norway
    10. 10Neurology Department, Oslo University Hospital, Oslo, Norway
    11. 11Research and Development, Norwegian Air Ambulance Foundation, Bodo, Norway
    12. 12Neurology Department, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia
    1. Correspondence to Professor Craig S Anderson; canderson{at}georgeinstitute.org.au

    Abstract

    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.

    • stroke
    • intracerebral haemorrhage
    • blood pressure lowering
    • individual participant data meta-analysis

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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    Footnotes

    • Contributors PMB, TJM, ECS and XW were responsible for first draft of the protocol, study conception and critical review of the current protocol. XW and LJW were responsible for statistical oversight. ZKL, CD, NS, KK, TGR, JW, RASS, EB and CSA were responsible for study conception and critical review of the current protocol.

    • Funding Blood pressure in Acute Stroke Collaboration has not received specific grants from any funding agency in the public, commercial or not-for-profit sectors. Potential trials for inclusion have reported their own funding. TJM is a British Heart Foundation clinical research training fellow. PMB is a Stroke Association Professor of Stroke Medicine. PMB and TGR are NIHR Senior Investigators. CSA is a Senior Research Fellow of the National Health and Medical Research Council of Australia.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators This protocol paper is written on behalf of the Blood pressure in Acute Stroke Collaboration (BASC, convener PMB). BASC-ICH comprises the following: ATACH-II: Adnan I Qureshi, Yuko Palesch; CHHIPS: John Potter, ENOS: Philip M Bath, Nikola Sprigg, Joanna M Wardlaw; FAST-Mag: Jeff Saver, Nerses Sanossian; GTN-1/2/3, RIGHT: Philip M Bath; ICH-ADAPT: Ken Butcher; IMAGES: Kennedy R Lees, Keith W Muir; INTERACT: Craig S Anderson; INTERACT2: Craig S Anderson, Hisatomi Arima; PILFAST: Gary Ford; RIGHT-2: Philip M Bath, Nikola Sprigg, Joanna M Wardlaw; SCAST: Eivind Berge, Else C Sandset; VENUS: Janneke Horn.

    • Patient consent for publication Not required.

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