NCT06731751Not yet recruiting
The Planetary Outcomes After Intracranial Haemorrhage Study
A Prospective, International Observational Study Assessing the Global Variation in Patient Characteristics, Management and Outcomes of Spontaneous Intracranial Haemorrhage.
Source: ClinicalTrials.gov · Last updated 12 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 1 Jan 2025
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- University of Cambridge
- Diseases
- Stroke
- NCT number
- NCT06731751
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jan 2025 to the primary completion date, 30 Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.