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RecruitingPHASE4INTERVENTIONAL

International Care Bundle Evaluation in Cerebral Hemorrhage Research

The I-CATCHER study is investigating a new set of treatments, called a 'care bundle', for people who have a specific type of stroke known as an intracerebral haemorrhage. This type of stroke, caused by bleeding in the brain, is very serious. The study wants to see if using this care bundle – which includes managing blood pressure, fever, and blood sugar – can improve how well patients recover three months after their stroke, compared to the usual care. Previous research in other countries suggests this approach could be helpful, and now the study is being done in places like the UK, Sweden, and Australia to confirm if it works for a wider group of patients.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Region Skane
Enrolment target
3,500
Start
07 Jan 2025
Estimated completion
01 Jul 2027

What is this study about?

Imagine your brain is a very important control centre, and sometimes a blood vessel can burst inside it, causing a type of stroke called an intracerebral haemorrhage. This can be a very serious event, and sadly, it can lead to lasting problems or even be life-threatening. Doctors are always looking for better ways to help people who have this kind of stroke.

This study, called I-CATCHER, is looking at a specific package of care, like a set of important steps, that doctors could use. This package includes things like quickly bringing down high blood pressure, treating fevers if they occur, and managing blood sugar levels. Scientists have already seen some promising results from this care package in other countries, suggesting it might really help patients recover better. Now, the I-CATCHER team wants to test this further in places like the UK, as well as Sweden and Australia, to see if it makes a real difference to people's recovery after three months.

The main goal of I-CATCHER is to find out if this special care package leads to better results for patients compared to the standard care they would usually receive. By doing this research, they hope to improve treatments and the chances of a good recovery for people experiencing this serious type of stroke within the next few years. It's about finding the best combination of care to give patients the best possible outcome.

Key takeaways

  • Tests a new 'care package' for a serious type of stroke.
  • Aims to improve recovery for patients with bleeding in the brain.
  • Compares a special treatment bundle to usual care.
  • Includes managing blood pressure, fever, and blood sugar.
  • Focuses on early, coordinated care to improve outcomes.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, aged 18 or older. Doctors would also need to have confirmed that you've had an intracerebral haemorrhage (bleeding in the brain) using a special brain scan. This diagnosis must have been made within 24 hours of your symptoms starting.

However, there are some reasons why you might not be able to join the study. For example, if you've already decided to limit medical care, or if you have a very serious illness that means you're not expected to live longer than six months (like terminal cancer). Also, if your brain bleed was caused by a brain tumour or a specific blood clot in the brain (cerebral venous thrombosis), you wouldn't be eligible.

If you show certain signs that your brain is under severe pressure at first, or if you are pregnant beyond 22 weeks, there would be extra discussions to see if the study is safe and appropriate for you.

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 doctors confirmed you've had bleeding in your brain (intracerebral haemorrhage) with a scan?
  3. Did your symptoms start less than 24 hours ago?
  4. Do you not have a pre-existing decision to limit your medical care?
  5. Is your brain bleed not related to a brain tumour or a specific type of blood clot?
  6. Are you not pregnant beyond 22 weeks, or if so, have you discussed risks with an obstetrician?
Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully described in the provided text. However, based on similar trials, if you were to participate in this study, it would likely involve receiving a specific package of care focused on managing your blood pressure, fever, and blood sugar right after your brain bleed. You would also have regular check-ups and assessments, which might include further brain scans and tests to monitor your condition and recovery over time, especially during the first three months after your stroke. The care you receive would be compared against standard care, and doctors would closely follow your progress to see which approach works best.

Potential risks and benefits

Participating in any medical study carries potential benefits and risks. The potential benefit of this study is that the special care package being tested might improve your recovery after an intracerebral haemorrhage compared to standard care. However, because it's a study, there's no guarantee that participating will directly benefit you, and you might receive the standard treatment. The care package involves treatments that are already used in medicine for other conditions, but combining them in this specific way is what's being studied. You would be closely monitored by medical staff throughout the study. Remember, you would always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

  • The University of Oklahoma Health
    Verified postcode
    Oklahoma City, United States· Recruiting
  • Royal Adelaide Hospital
    Verified postcode
    Adelaide, Australia· Recruiting
  • Monash Medical Centre
    Verified postcode
    Clayton, Australia· Recruiting
  • The George Institute for Global Health
    Verified postcode
    Sydney, Australia· Not yet recruiting
  • Health Sciences North/Health Sciences North Research Institute
    Verified postcode
    Greater Sudbury, Canada· Recruiting
  • Hamilton General Hospital
    Verified postcode
    Hamilton, Canada· Recruiting
  • Ottawa Hospital Research Institute
    Verified postcode
    Ottawa, Canada· Recruiting
  • Hong Kong University Hospital
    Verified postcode
    Hong Kong, Hong Kong· Recruiting
  • Landspitali University Hospital
    Verified postcode
    Reykjavik, Iceland· Recruiting
  • Avezzano Ospedale SS. Filippo e Nicola
    Verified postcode
    Avezzano, Italy· Recruiting
  • Citta di Castello Ospedale Città di Castello
    Verified postcode
    Città di Castello, Italy· Recruiting
  • Gubbio Ospedale di Gubbio e Gualdo Tadino
    Verified postcode
    Gubbio, Italy· Recruiting

Common questions

What is an intracerebral haemorrhage?

It's a type of stroke caused by bleeding directly into the brain tissue, rather than a clot blocking blood flow.

What is a 'care bundle'?

It's a group of several treatments or actions that are given together, often at specific times, to improve patient care.

What kind of treatments are in this care bundle?

It includes quickly lowering high blood pressure, treating fevers, and managing high blood sugar levels.

Why is this study being done in the UK?

Previous studies in other countries showed good results, and doctors want to see if this care package also helps patients in the UK and other similar high-income countries.

What is the main goal of the study?

To see if the special care package helps patients recover better three months after their brain bleed, compared to standard care.

How to find out more

Teresa Ullberg, MD, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "International Care Bundle Evaluation in Cerebral Hemorrhage …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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