The Planetary Outcomes After Intracranial Haemorrhage Study

NCT06731751 | Not Yet Recruiting

• 1 other identifier: PLOTICH
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Intracerebral Haemorrhage; Subarachnoid Haemorrhage (SAH)

Keywords

brain haemorrhage; intracerebral haemorrhage; subarachnoid haemorrhage

Outcome Measures

Primary Outcomes (1)

• Mortality

  30-day mortality or at discharge (whichever takes place first)

  30 days

Secondary Outcomes (4)

• Length of hospital stay

  30 days

• Complications

  30 days

• Modified Rankin Scale (mRS)

  30 days

• Glasgow Coma Scale

  30 days

Study Arms (1)

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).

Other: Management of spontaneous intracranial haemorrhage

Interventions

Management of spontaneous intracranial haemorrhage OTHER

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.

Spontaneous Intracranial Haemorrhage Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cambridge: lead

Related Publications (1)

• 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.

  PMID: 40897474 DERIVED

MeSH Terms

Conditions

Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sara Venturini, MBChB MPH

CONTACT

+44 (0)1223 331160; sv465@cam.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miss

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2024

Record last verified: 2024-12