Feasibility study for a platform trial on brain hemorrhage treatments
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
This study is trying to see if adults with brain hemorrhages are open to joining a larger trial that will test different treatments for their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 2 sites (Edinburgh, City Of Edinburgh and 1 other locations) |
| Trial ID | NCT06078020 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the feasibility of a platform trial for adults suffering from stroke due to intracerebral hemorrhage (ICH). The investigators will evaluate the acceptability of the trial among patients, their caregivers, and clinicians, while also estimating eligibility, willingness to participate, and adherence rates. Participants will provide demographic and clinical information and engage in interviews shortly after their diagnosis. The findings will inform the design of a larger platform trial that aims to investigate multiple treatments for ICH.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with symptomatic stroke due to spontaneous intracerebral hemorrhage.
Not a fit: Patients under 18 years old or those with hemorrhages due to macrovascular causes or extra-axial intracranial hemorrhage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and inclusive approach to treating patients with intracerebral hemorrhage.
How similar studies have performed: While traditional trials have struggled to find effective treatments for ICH, this platform approach is novel and aims to address existing gaps in research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edinburgh, City Of Edinburgh and 1 other locations
- The Royal Infirmary of Edinburgh — Edinburgh, City Of Edinburgh, United Kingdom (Recruiting)
- University Hospital Monklands — Airdrie, Lanarkshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rustam AS Salman, MA PhD FRCPE — University of Edinburgh
- Study coordinator: Rosemary Anderson
- Email: Rosemary.Anderson@ed.ac.uk
- Phone: +441315372944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.