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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Coagulation defects, purpura and other haemorrhagic conditions
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Children with immune thrombocytopenia (ITP) have low platelet counts (thrombocytopenia) due to an autoimmune process that destroys the platelets and the cells that produce them. Platelets are essential in blood clotting. ITP therefore causes an increased risk of bleeding.
However, serious bleeding is very uncommon in children, and the effects of treatment (such as steroids) have historically been the worst aspect of the disease. Current UK guidelines therefore recommend that children are not treated unless there is obvious bleeding; with less than 20% of children in the UK receiving
treatment. This has not resulted in any increase in life-threatening bleeding, however, we do not know whether small bleeds are still occurring internally. Small bleeds in the brain (intracranial) have been observed in adults with ITP and these may affect cognitive function. It may also be a warning sign for more significant bleeds.
We propose performing a special MRI brain scan in 30 children with ITP to look for
small bleeds. We will also take blood tests to identify risk factors to predict which patients will have significant bleeding. We will also include bleeding scores, cognitive testing and health-related quality of life tests in the children.
If we identify small bleeds in some patients, our data will be used to help design a UK-wide prospective MRI brain scan study in childhood ITP to incorporate the presence of intracranial bleeding into treatment pathways.
Our study will help identify children at risk of bleeding and may alter the treatment
approach from conservative to pro-active (with novel steroid-sparing drugs).
Alternatively, if our study finds no intracranial bleeding in children this adds weight to the evidence for continued conservative treatment and would be reassuring for parents and children.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
1. Patients who are unable to provide informed consent. 2. Patients who require sedation in order to undergo the MRI scanning procedure. 3. Patients prohibited from having an MRI because they have one of the following: α. Pacemakers, artificial heart valves or coronary stents. β. Aneurysm clips surgically implanted in the head. γ. Metal implants of any nature. δ. Cochlear implants. ε. Brain implanted electrodes. στ. Artificial limbs, calliper or surgical corsets. ζ. Metal fragments in the eyes or other body part. η. Dentures, plates or hearing aids. θ. Females with intrauterine contraceptive devices. 4. Any significant medical condition, laboratory abnormality or psychiatric illness that would prevent subjects from participating in the study. 5. Any medical condition, either current or past, that could potentially impair the ability of the subject to undergo the MRI scanning (e.g. epilepsy) and would place them at unacceptable risk if they were to participate in the study. 6. Any medical condition that would confound the ability to interpret data from the study. 7. Patients who are pregnant. A pregnancy test will be performed prior to the scan in appropriate patients.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by ITP SUPPORT ASSOCIATION .
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Read full details
for Trial ID: CPMS 40322
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