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

This study, called PLINTH, aims to improve how we find new treatments for strokes caused by bleeding in the brain, also known as intracerebral haemorrhage. Currently, finding effective treatments for this type of stroke is difficult. This is largely because previous studies tested only one treatment at a time and often struggled to include enough patients. PLINTH wants to change this by using a new approach called a 'platform study', which can test multiple treatments at once and include more people. Before launching a full-scale platform study, researchers need to understand if it's a good idea and if people affected by brain haemorrhage and their doctors would be happy to take part. This 'feasibility' study will gather information on how best to design and run such a trial, making sure it’s effective, inclusive, and truly helps patients.

At a glance

Status
Active not recruiting
Sponsor
University of Edinburgh
Enrolment target
169
Start
01 Oct 2023
Estimated completion
31 Mar 2026

What is this study about?

When someone has a stroke caused by bleeding in the brain (doctors call this an intracerebral haemorrhage, or ICH for short), it can be very serious. Right now, there isn't one specific treatment that doctors know works best for everyone. One of the main reasons for this is that clinical trials – which are studies to test new treatments – have faced challenges.

Often, past trials have looked at only one treatment at a time, and it has been hard to get enough patients to join. This new project, called PLINTH, wants to shake things up. It proposes a different type of trial called a 'platform study'. Imagine a platform study like a large train station where many different trains (treatments) can come and go, all at once. This way, many treatments can be tested more efficiently, and more people affected by brain bleeds could get the chance to participate.

This current study isn't actually testing treatments, though. It's a very important first step to make sure the bigger 'platform study' can work. Researchers want to find out three main things: whether patients, their families, and doctors are open to this new type of study; how many people might be able to join and keep taking part; and what's the best way to design the main platform study so it's as helpful and smooth as possible. By gathering this information, such as asking questions in interviews, they can make sure the future large study is the best it can be.

Key takeaways

  • This study is a planning stage for a bigger, more ambitious clinical trial.
  • It aims to find better ways to test treatments for strokes caused by bleeding in the brain.
  • Your input would help shape how future trials are designed.
  • Participation involves sharing information in a couple of interviews.
  • This study is being run in specific areas of Scotland (Lothian and Lanarkshire).
  • No new treatments are given in this study; it's purely for information gathering.

Who may be eligible?

To be considered for this study, you would need to be 18 years or older and have recently had a stroke caused by bleeding in the brain, which was confirmed by a brain scan. This must have happened between October 2023 and June 2025. You also need to live in certain areas of Scotland (NHS Lothian or NHS Lanarkshire).

There also needs to be some uncertainty about the best way to manage your condition, according to you (or your closest family member) and your doctor. You, or someone legally allowed to make decisions for you, should also be able to understand the study information and agree to take part.

However, you couldn't join if your brain bleed was caused by things like a large blood vessel problem, a tumor, an injury, or if it was a bleeding complication of a different type of stroke. Also, if your doctor feels it's not appropriate to approach you due to your health, or if you can't understand the information and there's no one to make decisions for you, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you recently had a stroke due to a brain bleed (intracerebral haemorrhage) that was confirmed by a scan?
  3. Do you live in the NHS Lothian or NHS Lanarkshire area in Scotland?
  4. Is there some uncertainty about your best medical management according to you (or your family) and your doctor?
  5. Is your brain bleed not related to a large blood vessel problem, tumor, or injury?
Answer every question to see your result.

What does participation involve?

If you, or your legal guardian/next of kin, agree to take part, the first step would be to watch a short video and read some written information explaining the study in more detail. This is to help you fully understand what's involved before giving your permission (called 'informed consent').

The research team would then collect some basic information about your health and background. You would also have two short interviews: one about 3 days after your stroke and another around 14 days after. These interviews are where you would share your experiences and thoughts. The study team would also routinely check some of your health records to see how you are getting on over time. The total duration of your active involvement would be limited to these two interviews and the initial information gathering.

Potential risks and benefits

Taking part in this study won't involve any new treatments or medications, so there are no direct medical risks from the study itself. The main benefit is that you would be contributing valuable information that could help design better studies in the future, potentially leading to new treatments for people who have had similar brain bleeds. The risks are minimal, mainly involving your time and the effort of participating in the interviews and sharing information. You are free to withdraw from the study at any time without giving a reason, and this would not affect your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The Royal Infirmary of Edinburgh
    Verified postcode
    Edinburgh, United Kingdom
  • University Hospital Monklands
    Verified postcode
    Airdrie, United Kingdom

Common questions

What is a 'platform study'?

It's a way to test many different potential treatments for a condition at the same time, making research faster and more efficient than traditional studies.

Will I receive any new treatment in this study?

No, this study is about planning for a future treatment trial. You will not receive any new treatments or medicines as part of this research, but your usual medical care will continue as normal.

Who is funding this research?

The information doesn't specify the funding source, but PLINTH involves a strong patient and public input, ensuring the study reflects what matters to those affected.

What happens to the information I provide?

Your information will be used to help researchers design the best possible future study for brain haemorrhage. It will be kept private and handled securely.

Do I have to take part if asked?

No, joining any research study is completely your choice. Your decision won't affect the care you receive from your doctors.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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