Status:
ACTIVE_NOT_RECRUITING
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Lead Sponsor:
University of Edinburgh
Collaborating Sponsors:
University of the West of Scotland
University of Nottingham
Conditions:
Cerebral Hemorrhage
Eligibility:
All Genders
18+ years
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 a...
Detailed Description
Background: Clinical trials have not found a treatment that works specifically for stroke caused by bleeding in the brain, known as intracerebral haemorrhage (ICH for short). Most clinical trials have...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2026
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT06078020
Start Date
October 1 2023
End Date
March 31 2026
Last Update
October 3 2025
Active Locations (2)
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1
The Royal Infirmary of Edinburgh
Edinburgh, City Of Edinburgh, United Kingdom, EH16 4SA
2
University Hospital Monklands
Airdrie, Lanarkshire, United Kingdom, ML6 0JS