BLOC-ICH Trial

A trial of a new drug to improve recovery after intracerebral haemorrhage (ICH)

 

The BLOC-ICH study aims to test whether a drug called Kineret® can reduce brain swelling and other markers of inflammation following ICH. If it does, then we plan larger trials to see if Kineret can improve recovery and quality of life.

What is the study about?

Inflammation occurs following brain injury. We know that inflammation is a key factor affecting recovery following ICH; higher inflammation is known to worsen outcomes for patients.

We have conducted various research studies which have found that inflammation is a promising target for therapy following ICH, with the potential to greatly improve recovery if it is reduced.

A naturally-occurring protein found in the body called interleukin-1 receptor antagonist (IL-1Ra) blocks inflammation.

Kineret®, a synthetic form of IL-1Ra, is a drug that is in clinical use for a number of inflammatory conditions. We have conducted smaller studies looking at the efficacy of this drug in reducing inflammation and improving recovery after haemorrhagic and ischaemic stroke, and have found that inflammation was reduced.

We are now testing this drug in 80 ICH patients across the UK to collect valuable data about its effect on brain swelling and other markers of inflammation following ICH.

What is an ICH?
Intracerebral haemorrhage (ICH) is a type of stroke caused by blood leaking out of a blood vessel into the tissue of the brain.
What is Kineret®?
Kineret® is an approved drug prescribed to treat inflammatory conditions such as moderate to severe rheumatoid arthritis. It is a man-made form of the natural substance IL-1Ra, which is an anti-inflammatory protein.
What is a clinical trial?

A clinical trial is a research study which explores whether a medicine or device is safe and effective for humans. Clinical trials can also look at whether a certain treatment is effective and safe in a particular group of people.

Before a clinical trial occurs, there is a long and careful research process.

Medicines or devices have often been tested in laboratories and in smaller groups of people before they go on to be tested in large populations. Clinical trials can help to determine if a new strategy, treatment or device improves patient outcomes, offers no benefit or causes unexpected harm. They follow strict scientific and ethical standards.

 

Information for new patients

Download our Participant Information Sheet (PDF), which tells you everything you need to know about what the trial involves.

Can I take part in the trial?

If you believe that you or your relative might be eligible, please speak to your doctor who will be able to tell you if you are able to participate and will provide you with further information.

If you have any general questions, please contact us.

 

Approval and funding

NHS ethical approval was gained from . ..

Funding statement

This project is funded by the NIHR through a Clinician Scientist Award to Dr Adrian Parry-Jones.

Disclaimer

The views expressed in this presentation are those of the author(s) and not necessarily those of the NHS, NIHR or the Department of Health.