PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study (NCT06078020) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
United Kingdom169 participantsStarted 2023-10-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.