The Planetary Outcomes After Intracranial Haemorrhage Study

Objectives Stroke is the second leading cause of death worldwide, with the greatest burden in LMICs. Haemorrhagic stroke or spontaneous intracranial haemorrhage (sICH), including intraparenchymal haemorrhage (IPH) and subarachnoid haemorrhage (SAH), has the greatest mortality and morbidity. Local management practices for haemorrhagic stroke vary greatly between geographical regions. This study aims to provide a comprehensive international overview of the patient characteristics, processes of care and short-term outcomes of patients being treated for sICH across high- and low-income settings.

Methods Study design: Prospective, international observational cohort study.

Setting: Any unit assessing patients with sICH is eligible to participate. Each participating unit will form a study team responsible for local approval processes, patient identification and data collection. Data will be collected online in anonymised form and will be analysed by the central study team according to a pre-determined statistical analysis plan.

Case definition:

Patients can be entered into the study if they meet the following criteria. • Patients of all ages with evidence of spontaneous intracranial haemorrhage (parenchymal, intraventricular and / or subarachnoid haemorrhage) on imaging (and absence of a history of trauma)

AND:

• Hospital admission for management of sICH All patients admitted to hospital meeting the above criteria during a given consecutive 30-day period during the study period will be included.

Results Data relating to the initial presentation, patient factors, management, and short-term outcomes of patients with sICH will be collected. The dataset includes patient demographics, details of the ictus, medical management, complications, timing and nature of surgical intervention (where applicable), post-intervention care and supporting management, and immediate post-operative complications. Primary outcome is 30-day mortality. Variation in processes of care and resources will be described. Where guidelines are available, outcomes will be assessed against guideline standards.

Conclusions This study aims to provide a global snapshot of the patient factors, management, processes of care and short-term outcomes of patients with spontaneous ICH and describe the global neurosurgical burden of haemorrhagic stroke. It will serve as a platform to facilitate future research and collaboration in global cerebrovascular surgery and stroke care.

Inclusion criteria

• Patients of any age with the presence of spontaneous intracranial haemorrhage (parenchymal, intraventricular and / or subarachnoid haemorrhage) on intracranial imaging (and absence of a history of trauma).

AND:

• Admission to hospital for sICH management. This includes admission for observation, conservative or interventional management to both ward-based and critical care settings.

Exclusion criteria

• Patients who have a clear history of trauma as the primary cause of the haemorrhage and therefore are diagnosed with traumatic intracranial haemorrhage.
• Patients with subdural or extradural haematomas but no clear history of trauma.
• Patients with intracranial haemorrhage occurring as a complication of a procedure or intervention (e.g. post-operative haematoma) or iatrogenic (e.g. after thrombolysis for ischaemic stroke).
• Patients who undergo elective (planned admission to hospital) or semi-elective (where a patient was initially admitted to hospital, then discharged from hospital and re-admitted for surgery) procedures.
• Patients re-admitted to hospital within 30 days of the initial admission with sICH (including those re-admitted for acute management of sICH-related complications).
• Patient presenting to the emergency department (ED) but discharged home from the ED immediately without a period of observation or admission to a ward.