PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study

NCT06078020 | Active Not Recruiting

• 3 other identifiers: AC23101HIPS/22/36325272
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to answer three uncertainties about the design of a platform study for adults with stroke due to intracerebral haemorrhage. The main things the investigators aim to find out are:

• The acceptability of a platform trial and its comparisons to brain haemorrhage survivors or their carers, and their clinicians.
• Estimates of eligibility, willingness to participate, diversity, representativeness, adherence, retention, data completion, and event rates of intermediate and clinical outcomes over time for each comparison.
• The most efficient platform trial design considering the findings of this feasibility study. Participants, or their welfare guardian, welfare attorney, or nearest relative will:
• Watch a video informing them about the study
• Read written information about the study
• Provide informed consent
• Permit collection of demographic and clinical details
• Provide information in interviews at \~3 and \~14 days after the onset of the stroke

Conditions

Cerebral Hemorrhage

Keywords

Platform study; Randomised controlled trial; Feasibility study

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  The frequency of people with incident ICH for whom there is at least one management uncertainty about ICH, with consent to participate in this feasibility study, and willingness to consider participating in a future PLINTH

  21 months

Secondary Outcomes (2)

• Estimates required for the design of an inclusive and representative future PLINTH

  21 months

• Feasibility of the consent process

  21 months

Interventions

Interview OTHER

Semi-structured interview to assess understanding and acceptability at 3+/-2 and 14+/-7 days after consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with stroke due to intracerebral haemorrhage

You may qualify if:

• People aged ≥18 years at the time of diagnosis with symptomatic stroke due to first-ever or recurrent spontaneous (non-traumatic) ICH, most likely to be due to cerebral small vessel disease, confirmed by brain imaging between 1 October 2023 and 30 June 2025 inclusive
• One or more management uncertainties exist about the patient's management according to the patient/nearest relative and their responsible clinician
• Patient or their nearest relative can be approached for consent to participation in this feasibility study with the aid of simple information delivered by Tailored Talks
• Residential postcode in the National Health Service (NHS) Lothian or NHS Lanarkshire regions of Scotland

You may not qualify if:

• People aged \<18 years at the time of ICH diagnosis
• Exclusively extra-axial intracranial haemorrhage or ICH definitely attributable to a macrovascular cause (e.g. aneurysm, arteriovenous malformation, cavernoma, cerebral venous sinus thrombosis), tumour, trauma or haemorrhagic transformation of an ischaemic stroke
• Responsible clinician deems it inappropriate to approach the patient or their nearest relative (e.g. death appears imminent)
• Mental incapacity and no nearest relative, welfare attorney or welfare guardian available at the time of approach
• Patient died before approached for consent

Sponsors & Collaborators

• University of Edinburgh: lead
• University of the West of Scotland: collaborator
• University of Nottingham: collaborator

Study Sites (2)

The Royal Infirmary of Edinburgh

Edinburgh, City Of Edinburgh, EH16 4SA, United Kingdom

Location

University Hospital Monklands

Airdrie, Lanarkshire, ML6 0JS, United Kingdom

Location

Related Links

• Study website

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rustam AS Salman, MA PhD FRCPE

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 11, 2023
• Study Start: October 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: March 31, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: One year after completion of the study
• Access Criteria: Data collected or generated by the study may be transferred to any external individuals or organisations outside of the Sponsoring organisation(s) under a defined data sharing agreement.

Locations

GB (2)