Patient Information Sheet for Parent Or Guardian of Child Relative of Congenital TTP Patient

>>>>>(Form to be on Trust headed paper<<<<<

Patient Information Sheet (PIS) for Parent/Guardian of Child Relative of Congenital TTP Patient

The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (TTP Registry)

Your son/daughter is being invited to take part in a research study. Before you decide, if he or she should take part it is important to understand why the research is being done and what it will involve. Please take time to read the following information carefully, and discuss it with others if you wish, before you make a decision. Ask us if there is anything that is not clear or if you would like more information.

Why are we doing the study? Your child’s relative presented with an episode of Thrombotic Thrombocytopenic Purpura, or TTP for short, which is a rare disorder. His or her doctor will have explained what this condition means, but in brief, it is an acute disorder that may affect any organ in the body and requires immediate treatment.

TTP is a rare disorder and we are collecting information from patients admitted with TTP throughout the UK. The study is a Registry of TTP admissions in the UK, therefore, with all of the UK involved we hope to gain a better understanding of TTP. With a better understanding of this disorder we hope to improve the diagnosis, treatment and recovery of patients admitted with TTP.

Why have I been chosen and what does being a relative of a congenital TTP Patient in the Registry involve? Most TTP cases are caused by reduced levels of an enzyme called ADAMTS 13. As part of standard clinical procedure a number of blood samples are taken when a patient is admitted for a suspected TTP episode, and one of these blood samples (a citrate sample) is used to measure levels of ADAMTS13. The Haemostasis Research Unit (HRU) at University College London (UCL) is one of the specialist sites in the UK that can carry out this testing, and it is likely that your child’s relative had their ADAMTS13 level analysed at the HRU. This relative’s ADAMTS13 assay results suggested that they had a congenital form of TTP (which means an inherited form of TTP), and this was confirmed when their DNA was analysed.

UK TTP Registry: PIS for Parent/Guardian of Child Relative of Congenital TTP Patient, Version 2.0, 6th October 2010 Page 1 of 3 As a result of this diagnosis your son/daughter now has the opportunity to be tested for the congenital form of TTP as well. In order to do this we require your consent to include your child in the UK TTP Registry and take a blood sample so we can extract and analyse your child’s DNA. As part of this study we also require your consent to store your son’s/daughter’s DNA at the Haemostasis Research Unit so it may be analysed in the future, but only in research related to TTP.

The DNA analysis results from all the patients participating in The UK TTP Registry will be looked at together, to see if any of the genes identified have any relevance to the risk of presenting with TTP, the potential responses to treatment or the risk of relapse and the prevalence of congenital TTP. If your child has congenital TTP he/she will be monitored and offered counselling as well as provided with any necessary treatment.

Who do I contact if I have any questions or need further information? Any member of the team is more than happy to discuss any aspect of the treatment with you. Healthcare professionals can unfortunately use terms which are commonplace for us yet bewildering and confusing for patients, especially as different terms can often mean the same thing. Please ask if you haven’t understood anything or are confused by the terms used.

Contact details are provided below:

>>>>>Please enter local contact details<<<<<<

Do I have to take part?

No. It is up to you. We will ask you to consent on your son’s/daughter’s behalf and then ask if you would sign a form. If aged 6 years or more, your son/daughter will then be given information about the study and asked to complete an assent form, (which you can help to complete if necessary). We will give you a copy of the information sheet(s) and a copy of the signed form(s) to keep. You are free to withdraw your consent at any time during the research without giving a reason. Should you decide to withdraw your consent, all the information and samples submitted for the UK TTP Registry will be deleted/destroyed. If you decide to withdraw your consent, this will not affect the care you or your son/daughter receives. If you have any concerns about participating in research the Patient Advisory and Liaison Service (PALS) will provide you with independent information and advice at your hospital.

What are the benefits of taking part in this research?

UK TTP Registry: PIS for Parent/Guardian of Child Relative of Congenital TTP Patient, Version 2.0, 6th October 2010 Page 2 of 3 We hope to use the data we collect for the UK TTP Registry in order to gain a better understanding of TTP. As this is a rare disorder, it is vital that as many patients in the UK are involved as possible, that way we can collect a meaningful amount of data. The information from this study may help us to improve future treatment for patients with TTP. We also need to find out if your son/daughter has congenital TTP, as they may need treatment in the future.

Compensation arrangements You will receive reimbursement for travel expenses fro any visit that is required specifically for the purpose of taking part in the UK TTP Registry. We do not anticipate that this will be the case as the blood tests are considered to occur as part of routine care, but occasionally an extra visit may be scheduled for your child. The institution will not receive any funds for conducting this study. University College London Hospitals (UCLH) is sponsoring this study and providing indemnity in the event that any subjects are harmed as a result of taking part in the study. Any claims for clinical negligent harm can be made through the NHS Clinical Negligence Scheme for Trusts (CNST) in England, Welsh Risk Pool (WRP) in Wales, the Risk Pooling scheme run by the Northern Ireland Office or through The Clinical Negligence and Other Risks Scheme (CNORIS) in Scotland.

Data storage and review

As the parent/guardian consenting on your child’s behalf to participate in the study, you must agree to your son’s/daughter’s hospital notes and clinical study data being reviewed by researchers conducting the research, UCLH personnel for purposes of monitoring and auditing and Regulatory Agencies for purposes of external inspections. Your child will be allocated a specific study identification number when they are enrolled in this trial and this will be used to identify them throughout your participation. Personal information will be retained in a confidential manner and will not be available to external personnel.

Who has reviewed this study? All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee (REC). The REC’s role is to protect the safety, rights, wellbeing and dignity of patients participating in research projects. This study has been reviewed and given a favourable ethical opinion by the Lewisham Research Ethics Committee (now known as South East London REC 5).

Thank you for taking the time to read this information sheet.

UK TTP Registry: PIS for Parent/Guardian of Child Relative of Congenital TTP Patient, Version 2.0, 6th October 2010 Page 3 of 3