Cerebral HemorrhagePLINTHNCT06078020
PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
An observational study of Cerebral Hemorrhage, run by University of Edinburgh at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Hemorrhage
- What is being tested?
- Interview
- How many people
- 169 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Oct 2023to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with stroke due to intracerebral haemorrhage
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospital Monklands
Airdrie, Lanarkshire, ML6 0JS
The Royal Infirmary of Edinburgh
Edinburgh, City Of Edinburgh, EH16 4SA
About this study
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:
Read more
- 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
Read the 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]).
- Conditions
- Cerebral Hemorrhage
- Being tested
- Interview
- Keywords
- Platform study, Randomised controlled trial, Feasibility study
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Semi-structured interview to assess understanding and acceptability at 3+/-2 and 14+/-7 days after consent
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 months
Secondary outcomes (2)
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
Measured: 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)
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Oct 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of the West of Scotland, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Rustam AS Salman, MA PhD FRCPE, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078020
- Sponsor's protocol ID
- AC23101
- Other IDs
- HIPS/22/36, 325272
- Acronym
- PLINTH
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLatform Study for INTracerebral Haemorrhage (PLINTH): Community-based Feasibility Study
- ClinicalTrials.gov ID
- NCT06078020
- Acronym / sponsor ID
- PLINTH / AC23101
- Conditions
- Cerebral Hemorrhage
- Keywords
- Platform study, Randomised controlled trial, Feasibility study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of the West of Scotland, University of Nottingham
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with stroke due to intracerebral haemorrhage
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewSemi-structured interview to assess understanding and acceptability at 3+/-2 and 14+/-7 days after consent | Other | – |
Primary outcome
Recruitment rate
Time frame: 21 months
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
2 secondary outcomes
Estimates required for the design of an inclusive and representative future PLINTH
Time frame: 21 months
Feasibility of the consent process
Time frame: 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rustam AS Salman, MA PhD FRCPE principal investigator
University of Edinburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hemorrhage, run by University of Edinburgh at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.