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NCT06078020
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Conditions: Cerebral Hemorrhage
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 169
Sponsor: University of Edinburgh
Location: The Royal Infirmary of Edinburgh Edinburgh City Of Edinburgh
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
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 \
Source: ClinicalTrials.gov (NCT06078020). StuddyBuddy aggregates publicly available trial information.