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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cerebral Hemorrhage
• Intervention / Treatment: Other: Interview

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]).

• Study Type: Observational
• Enrollment (Actual): 169

Contacts and Locations

Study Locations

• United Kingdom
  • City Of Edinburgh
    • Edinburgh, City Of Edinburgh, United Kingdom, EH16 4SA
      • The Royal Infirmary of Edinburgh
  • Lanarkshire
    • Airdrie, Lanarkshire, United Kingdom, ML6 0JS
      • University Hospital Monklands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with stroke due to intracerebral haemorrhage

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The frequency of people with incident ICH for whom there is at least one management uncertainty about ICH, with consent to participate in this feasibility study, and willingness to consider participating in a future PLINTH	21 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimates required for the design of an inclusive and representative future PLINTH	Demographic and clinical characteristics of people incident with ICH who would participate in a future PLINTH	21 months
Feasibility of the consent process	Acceptability to participants of an electronic approach to providing personalised information about their care and shared decision making about potential eligibility for recruitment to a future PLINTH (video abstract and Tailored Talks)	21 months

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: University of Nottingham; University of the West of Scotland
• Investigators: Principal Investigator: Rustam AS Salman, MA PhD FRCPE, University of Edinburgh

Publications and helpful links

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Feasibility study; Platform study
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Cerebral Hemorrhage; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: AC23101; HIPS/22/36 (Other Grant/Funding Number: Chief Scientist Office of the Scottish Government); 325272 (Other Identifier: Integrated Research Application System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once the data retention period is over, study data will be de-identified and archived in the University of Edinburgh's secure DataShare (https://datashare.ed.ac.uk/), an open access repository.
• IPD Sharing Time Frame: One year after completion of the study
• IPD Sharing Access Criteria: Data collected or generated by the study may be transferred to any external individuals or organisations outside of the Sponsoring organisation(s) under a defined data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No