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

Launched by UNIVERSITY OF EDINBURGH · Oct 5, 2023

Keywords

ClinConnect Summary

The PLINTH study is looking into ways to improve the treatment of adults who have experienced a specific type of stroke called intracerebral hemorrhage, which is bleeding in the brain. Researchers want to find out how acceptable a new type of clinical trial is to patients, their families, and doctors, and to learn about how many people might want to participate. They will also gather information on how well participants stay with the study and how effective different treatments are over time.

To be eligible for this study, participants must be at least 18 years old and have had a stroke due to bleeding in the brain that was confirmed by imaging tests. They should live in the NHS Lothian or NHS Lanarkshire areas of Scotland. If you or a loved one are interested in participating, you'll receive a video and written information about the study to help you understand what it involves. You will be asked for your consent to take part and share some personal health information. Additionally, there will be interviews approximately three and fourteen days after the stroke to gather more insights. Your participation can help shape future treatments for this condition.

Gender

ALL

Eligibility 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