Clinical trial NCT06078020: PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Official title: PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Hemorrhage
Keywords: Platform study
Randomised controlled trial
Feasibility study
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: University of the West of Scotland
name: University of Nottingham
First posted: 2023-10-11
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with stroke due to intracerebral haemorrhage

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 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

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 studied one treatment at a time and included only 1 in 10 people with ICH. That's why each clinical trial recruited only 77 participants on average. A PLatform trial for INTracerebral Haemorrhage (PLINTH) will change this by investigating several treatments and giving everyone with ICH an opportunity to take part.

Aim: The investigators intend PLINTH to be large, inclusive, efficient and assess several treatments for ICH. First, a feasibility study is needed to work out whether PLINTH can succeed.

Methods: The investigators will find people recently diagnosed with ICH in Lothian and Lanarkshire and invite them to take part in a feasibility study. The investigators will provide them with personalised information using Tailored Talks. The investigators will find out if PLINTH is acceptable to people with ICH, carers, and doctors. The investigators will use data that are collected routinely to follow participants' progress. Characteristics and outcomes of participants will help design PLINTH.

Patient \& public involvement: The investigators asked ICH survivors about PLINTH: 92% strongly agreed that working out how to do a platform study to find treatments for ICH is a priority. An ICH survivor is in the study team.

Dissemination: The investigators will produce easy access reports and share them with people with ICH, carers, healthcare professionals, and the public in their preferred format (printed, email, social media, and on the Research to Understand Stroke due to Haemorrhage website \[http://www.RUSH.ed.ac.uk\]).

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

Primary outcomes:
measure: Recruitment rate
timeFrame: 21 months
Secondary outcomes:
measure: Estimates required for the design of an inclusive and representative future PLINTH
timeFrame: 21 months
measure: Feasibility of the consent process
timeFrame: 21 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: The Royal Infirmary of Edinburgh
state: City Of Edinburgh
city: Airdrie
country: United Kingdom
facility: University Hospital Monklands
state: Lanarkshire
Study officials:
affiliation: University of Edinburgh
name: Rustam AS Salman, MA PhD FRCPE
role: PRINCIPAL_INVESTIGATOR
References: