Woman and Man
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Extract
Background and study aims We are interested in developing a new treatment for patients with a stroke caused by bleeding into the brain (intracerebral haemorrhage). In the hours to days after bleeding occurs, we know that inflammation occurs in the brain around the blood clot. Although inflammation is the body's natural response to injury, when it continues unchecked it can worsen damage. We know that it does worsen damage after an intracerebral haemorrhage and we want to investigate whether blocking inflammation can improve outcomes. Between the blood and brain, there is a blood-brain barrier. How much of a drug can get to where it needs to act in the brain is largely governed by how well it can cross the blood-brain barrier. This makes the blood-brain barrier very important in drug development, as drugs to block brain inflammation have to cross it to get to where they need to go. However, when the brain is damaged, the blood-brain barrier can become leaky. We know very little about this after intracerebral haemorrhage. This study will determine how leaky the blood-brain barrier is in the first three days after intracerebral haemorrhage. Who can participate? Adult intracerebral haemorrhage patients. What does the study involve? Participants undergo an MRI scan to measure leakiness in the first 3 days after their stroke. Twenty of these patients will go on to have a PET scan to show brain inflammation 2- 7 days after their stroke. By putting the two scans together, we will be able to estimate how much of an anti-inflammatory drug will get to inflamed areas in the brain. This will help us to know how much of the drug to give and when to give it in subsequent studies. What are the possible benefits and risks of participating? There are no benefits to participation in the study but this will be made clear to participants at first approach. Participants will be exposed to ionising radiation during the PET scan. The maximum dose that is received as part of the scan is equivalent to 1.4 years of background radiation in the UK. There may also be discomfort associated with the blood sampling and MRI/PET scan. Where is the study run from? Salford Royal NHS Foundation Trust (UK). When is the study starting and how long is it expected to run for? October 2015 to August 2017. Who is funding the study? National Institute for Health Research (UK). Who is the main contact? Sharon Hulme
Inclusion criteria
- Topic: Stroke; Subtopic: Acute Care; Disease: In hospital study, Community study