Assessing the global variation in patient characteristics, management and short-term outcomes of spontaneous intracranial haemorrhage worldwide: a protocol for a global observational prospective multicentre study (the PLOT-ICH study).

INTRODUCTION

Stroke is the second leading cause of death worldwide, with the greatest burden in low- and middle-income countries (LMICs). Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the highest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. The Planetary Outcomes after Intracranial Haemorrhage study aims to provide a global snapshot of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings. It will also describe variation seen in care processes and available resources and time delays to receiving care. A greater understanding of the current state of sICH care is essential to identify possible interventions and targets for improved standards of care in all settings.

METHODS AND ANALYSIS

We describe a planned prospective, multicentre, international observational cohort study of patients admitted to hospital for management of sICH. We will include patients of all ages presenting to hospital with imaging evidence of sICH (IPH, intraventricular haemorrhage and/or SAH). The study will collect patient, care process and short-term outcome data, following patients for up to 30 days (or until discharge or death, whichever occurs first). Any centre globally where patients with sICH are admitted and managed can participate, targeting a sample size of 712 patients. The study will recruit centres worldwide through pre-existing research networks and by dissemination through neurosurgical and stroke conferences and courses. Each participating centre will complete a site questionnaire alongside patient data collection.

ETHICS AND DISSEMINATION

The study has received ethical approval by the University of Cambridge (PRE.2024.070). Participating centres will also confirm that they have undergone all necessary local governance procedures prior to starting local data collection. The findings will be disseminated via open access peer-reviewed journals, relevant conferences and other professional networks and lay channels, including the study website (https://plotich.org/) and social media channels (@plotichstudy).

TRIALS REGISTRATION NUMBER

NCT06731751.