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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).

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posted on 2019-08-14, 16:18 authored by TJ Moullaali, X Wang, LJ Woodhouse, ZK Law, C Delcourt, N Sprigg, K Krishnan, TG Robinson, JM Wardlaw, R Al-Shahi Salman, E Berge, EC Sandset, CS Anderson, PM Bath, BASC Investigators
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.

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.

History

Citation

BMJ Open, 2019;9:e030121.

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Cardiovascular Sciences

Version

  • VoR (Version of Record)

Published in

BMJ Open

Publisher

BMJ Publishing Group

eissn

2044-6055

Acceptance date

2019-06-14

Copyright date

2019

Available date

2019-08-14

Publisher version

https://bmjopen.bmj.com/content/9/7/e030121

Notes

Additional material for this paper is available online. To view these files, please visit the journal online (http://dx.doi.org/10.1136/bmjopen-2019-030121).

Language

en

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