StrokePLOT-ICHNCT06731751
The Planetary Outcomes After Intracranial Haemorrhage Study
An observational study of Stroke and Intracerebral Haemorrhage, run by University of Cambridge.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Intracerebral Haemorrhage, Subarachnoid Haemorrhage (SAH)
- What is being tested?
- Management of spontaneous intracranial haemorrhage
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, International Observational Study Assessing the Global Variation in Patient Characteristics, Management and Outcomes of Spontaneous Intracranial Haemorrhage.
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.
Read more
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.
Read the 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.
- Being tested
- Management of spontaneous intracranial haemorrhage
- Keywords
- brain haemorrhage, intracerebral haemorrhage, subarachnoid haemorrhage
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of spontaneous intracranial haemorrhageOther
Admission to hospital for spontaneous intracranial haemorrhage management. This includes admission for observation, conservative or interventional (surgical or endovascular) management to both ward-based and critical care settings.
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous Intracranial Haemorrhage Patients | 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). Receives: Other: Management of spontaneous intracranial haemorrhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
30-day mortality or at discharge (whichever takes place first)
Measured: 30 days
Secondary outcomes (4)
Length of hospital stay
Time in hospital, from admission to discharge
Measured: 30 days
Complications
Peri-operative and disease specific complications (e.g. hydrocephalus, seizures, delayed cerebral ischaemia, return to operating theatre)
Measured: 30 days
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) as assessment of neurological function at discharge from hospital.
Measured: 30 days
Glasgow Coma Scale
Glasgow Coma Scale (GCS) at discharge from hospital.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Venturini, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731751
- Sponsor's protocol ID
- PLOTICH
- Acronym
- PLOT-ICH
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Venturini S, Clark D, Smith BG, Hobbs L, Bath MF, Mee H, Still M, Mediratta S, Soliman MA, Kohler K, Whiffin CJ, Katambo E, Korhonen TK, Tetri S, Bankole NDA, Rutabasibwa N, Bhebhe A, Munusamy T, Tirsit A, Park KB, Budohoski K, Wahjoepramono P, Tamborska A, Saylor D, Khan T, Khattak AF, Figaji A, Kolias AG, Bashford T, Joannides A, Martin M, Trivedi RA, Hutchinson PJ; PLOT-ICH Collaborative. 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). BMJ Open. 2025 Sep 2;15(9):e100361. doi: 10.1136/bmjopen-2025-100361.
PubMed 40897474
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, International Observational Study Assessing the Global Variation in Patient Characteristics, Management and Outcomes of Spontaneous Intracranial Haemorrhage.
- ClinicalTrials.gov ID
- NCT06731751
- Acronym / sponsor ID
- PLOT-ICH / PLOTICH
- Keywords
- brain haemorrhage, intracerebral haemorrhage, subarachnoid haemorrhage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spontaneous Intracranial Haemorrhage Patients | – | Other: Management of spontaneous intracranial haemorrhagePatients 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
- Admission to hospital for sICH management. This includes admission for observation, conservative or interventional management to both ward-based and critical care settings.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Management of spontaneous intracranial haemorrhageAdmission to hospital for spontaneous intracranial haemorrhage management. This includes admission for observation, conservative or interventional (surgical or endovascular) management to both ward-based and critical care settings. | Other | Spontaneous Intracranial Haemorrhage Patients |
Primary outcome
Mortality
Time frame: 30 days
30-day mortality or at discharge (whichever takes place first)
4 secondary outcomes
Length of hospital stay
Time frame: 30 days
Complications
Time frame: 30 days
Modified Rankin Scale (mRS)
Time frame: 30 days
Glasgow Coma Scale
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 40897474Venturini S, Clark D, Smith BG, Hobbs L, Bath MF, Mee H, Still M, Mediratta S, Soliman MA, Kohler K, Whiffin CJ, Katambo E, Korhonen TK, Tetri S, Bankole NDA, Rutabasibwa N, Bhebhe A, Munusamy T, Tirsit A, Park KB, Budohoski K, Wahjoepramono P, Tamborska A, Saylor D, Khan T, Khattak AF, Figaji A, Kolias AG, Bashford T, Joannides A, Martin M, Trivedi RA, Hutchinson PJ; PLOT-ICH Collaborative. 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). BMJ Open. 2025 Sep 2;15(9):e100361. doi: 10.1136/bmjopen-2025-100361.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Intracerebral Haemorrhage, run by University of Cambridge.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Venturini, MBChB MPH (+44 (0)1223 331160, sv465@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06731751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.