>>>>>Form to be on Trust headed paper<<<<<
Patient Information Sheet (PIS) for Child Relative (11-16 years)
of Congenital TTP patient
The United Kingdom Thrombotic Thrombocytopenic
Purpura Registry (TTP Registry)
We are asking if you would like to join in a research project called the UK TTP
Registry. Before you decide if you want to join in, it is important to understand
why the research is being done and what it will involve for you. So please
consider this leaflet carefully. Talk to your family, friends, doctor or nurse if
you want to. You do not have to decide straight away, please take time to
make your decision and ask us or your parent/guardian if there is something
you do not understand or if you would like more information.
Why are we doing the study?
Your relative has recently been in hospital for an episode of Thrombotic
Thrombocytopenic Purpura, or TTP for short, which is a rare illness. Their
doctor will have explained what this means, but to say it simply, it is an illness
that can affect different parts of your body and needs to be treated straight
away.
As part of this study we want to collect some information about patients in the
UK who had TTP to have a better understanding of this illness.
Why have I been chosen and what does being a relative of a
Congenital TTP Patient in the Registry involve?
Most TTP episodes are caused by reduced levels of an enzyme called
ADAMTS 13. As part of normal medical care a number of blood samples are
taken when a patient is admitted with TTP and one of these blood samples is
used to measure levels of ADAMTS13. The Haemostasis Research Unit
(HRU) at University College London (UCL) is one of the special sites in the
UK TTP Registry: PIS for Child relative (11-16years) of Congenital TTP Patient, version 2.0, 6th October 2010
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UK that can carry out this testing, and it is likely that your relative’s
ADAMTS13 blood sample was sent to the HRU.
Your relative’s ADAMTS13 and DNA test results showed that they have a type
of TTP called Congenital TTP, which is an inherited form of TTP. Because
your relative has Congenital TTP you can now be tested as well as part of the
UK TTP Registry. If you would like to take part in the UK TTP Registry, we
will need your permission to extract and store this DNA at the Haemostasis
Research Unit so it may be looked at in the future, but only in research related
to TTP. In order carry out this testing, we will need to take a blood sample
from you (1 teaspoonful of blood). The blood test will take approximately 2
minutes and will not hurt. The blood test will not make you ill afterwards and
you will not need to stay off school.
The DNA from all the patients taking part in the UK TTP Registry will be
looked at together, to see if people with some types of DNA are more likely to
get TTP and if some medicines are better for them than others.
Who do I contact if I have any questions or need further
information?
Please ask any member of the team or your parents/guardians if there is
anything you don’t understand or are confused by the words used.
Contact details are provided below:
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Do I have to take part?
No. It is up to you. We will ask you for your assent (or consent if you are in
Scotland) and then ask if you would complete a form. We will give you a copy
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of this information sheet and your signed form to keep. You are free to stop
taking part at any time during the research without giving a reason. If you
decide to stop, this will not affect the care you receive.
What are the benefits of taking part in this research?
We hope to understand more about TTP. We cannot promise the study will
help you but the information we get might help treat young people with TTP
with better medicines in the future. We also need to find out if you have
Congenital TTP, as you may need treatment in the future.
What if new information becomes available?
Sometimes during research, new things are found out about the research
topic. Your doctor will tell you about this if this happens.
Who is organising and funding the research?
The hospital and your doctor are not being paid to include you in this study.
University College London Hospitals (UCLH) is sponsoring this study.
Data storage and review
We will keep your information in confidence. This means we will only tell
those who have a need or right to know. Wherever possible, we will only send
out information that has your name and address removed.
Who has reviewed this study?
Before any research goes ahead it has to be checked by a Research Ethics
Committee. They make sure that the research is fair. Your project has been
checked by the Lewisham Research Ethics Committee (now known as South
East London REC 5).
Thank you for reading this – please ask any questions if you need to.
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