Form to be on Trust headed paper
Patient Information Sheet (PIS) for Children/Young People aged 11-16 years
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?
You have recently been in hospital foran episode of Thrombotic Thrombocytopenic Purpura, or TTP for short, which is a rare illness. Your 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.
What happens after I have been treated?
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 that can carry out this testing, and it is likely that your ADAMTS13 blood sample was sent to the HRU.
When you have left hospital and recovered from your TTP episode your doctor will take another sample to test for ADAMTS13 which is part of normal medical care, and you will be asked if you would like to take part in this research project. As part of the UK TTP Registry we will ask for your permission to record and store some medical information from your stay in hospital. This information will include how ill you were when you came into hospital, and what kind of medicines you were given. We would also like to record your routine blood test and ADAMTS13 test results.
As part of the UK TTP Registry we also need your permission to take an extra blood sample(called EDTA) which we will use to remove your DNA, this DNA will then be stored frozen at the HRU. This EDTA sample will be taken at the same time as your blood test for ADAMTS13, so you will not need another blood test for joining the Registry. A serum sample, (taken as part of normal medical care with your other remission samples), will also be stored at the HRU and used to lookat tests for TTP if you decide to take part in this study. 3 teaspoons of blood will be collected in total. 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.
Sometimes your DNA will be looked at to see if you have a type of TTP called Congenital TTP, which is an inherited form of TTP. Your doctor will tell you about this if he/she thinks you may have it, and your family may be tested for it as well.
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 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.
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. This 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.
UK TTP Registry: PIS for Children/Young People (11-16years), version 2.0, 6th October 2010
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