Clinical trial NCT06731751: The Planetary Outcomes After Intracranial Haemorrhage Study
Official title: A Prospective, International Observational Study Assessing the Global Variation in Patient Characteristics, Management and Outcomes of Spontaneous Intracranial Haemorrhage.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stroke
Intracerebral Haemorrhage
Subarachnoid Haemorrhage (SAH)
Keywords: brain haemorrhage
intracerebral haemorrhage
subarachnoid haemorrhage
Lead sponsor: University of Cambridge
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult and paediatric patients meeting the case definition criteria and admitted to a participating institution with a sICH during the selected 30-day study period are eligible for inclusion in the study.

Brief summary: Over twelve million strokes occur worldwide every year, and stroke is the second most common cause of death globally. Strokes happen because blood supply to the brain is damaged. This can be due to a blockage (ischaemic stroke) or a bleed (haemorrhagic stroke - or intracranial haemorrhage). Intracranial haemorrhage can be life-threatening and patients with this type of stroke can be very sick, requiring urgent medical care including medications, close monitoring, and sometimes surgery.

Strokes happen worldwide, but over 80% of stroke cases and associated death and disability occur in low- and middle- income countries (LMICs), where resources to manage them can be limited. However, the differences in how patients present, the hospital care they receive, and their overall outcomes when compared to high-income countries (HICs) patients are not fully understood. There are many stroke-related deaths occurring each year around the world, especially among those who have presented with an intracranial haemorrhage, and if survival rates are to be improved, high-quality data is needed to help us better understand where the improvements in care are required in different health settings.

Run and funded by the University of Cambridge, this study will collect data on all patients across all ages during a one-month period who undergo treatment for spontaneous intracranial haemorrhage, both medical and surgical. We will include patients from any hospital across the world that treats patients with this condition, collecting data from their admission to hospital until their discharge, death or up to 30 days from their presentation.

This is an observational study, so we are only observing patients care and management, not making any direct changes to their treatment. We will also be asking each centre to complete a written survey, to better understand some of the more complex areas which are important for the care of intracranial haemorrhage patients such as hospital resources available, and the potential barriers they face in accessing appropriate healthcare.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days
measure: Complications
timeFrame: 30 days
measure: Modified Rankin Scale (mRS)
timeFrame: 30 days
measure: Glasgow Coma Scale
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: