Adult TTP Patient - Patient Information Sheet

Form to be on Trust headed paper

Patient Information Sheet(PIS)

The United Kingdom Thrombotic Thrombocytopenic Purpura Registry(TTP Registry)

You are being invited to take part in a research study. Before you decide it is important for you 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. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Thank you for reading this.

Why are we doing the study?

You have presented with an episode of Thrombotic Thrombocytopenic Purpura or TTP for short, which is a rare disorder. Your doctor will have explained what this condition means but in brief it is an acute disorder that may affect any organ 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 admission in the UK. Therefore, with all of the UK involved, we hope to gain a better understanding of TTP.

Why have I been chosen and what does theUK TTPRegistry involve?

The majority of TTP cases are caused by reduced levels of an enzyme called ADAMTS13. As part of standard clinical care a number of blood samples are taken when a patient is admitted for a suspected TTP episode, and one of these samples (a citrate sample) is used to measure levels of ADMATS13. The Haemostasis Research Unit (HRU) atUniversity College London (UCL) is one of the specialist sites in the UK that can carry out this testing, and it is likely that your ADAMTS13 level was analysed at the HRU. For those sites that analyse ADAMTS 13, you will be asked during the consent process if you will allow some of this sample to be sent to UCL/UCLH. This will allow a large number of samples to be collected so we can analyse them as a group/subgroup to help further research, to understand TTP and related thrombotic microangiopathies.

When you have been discharged from hospital and are in remission your doctor will take another sample to measure ADAMTS13 as part of standard care, and you will be asked if you would like to take part in the UK TTP Registry. This is to allow information, such as the symptoms you had on admission, treatment and complications during your hospital stay to be recorded in the UK TTP Registry. Other data that we require for the registry are your routine blood test results from your stay in hospital and your ADAMTS13 results. As part of this project we will also ask you for an extra blood sample, called an EDTA sample, from which DNA will be removed, 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 another blood test for the Registry will not be necessary. A serum sample, (taken as part of standard care with your other remission samples),will also be stored at the HRU and used to analyse current and future tests relevant to TTP if you consent to participate in this study.

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. If, from the ADAMTS 13 assays there is a suggestion that you may have congenital TTP (an inherited form of TTP), which is confirmed when the DNA is analysed, you will be informed by your local haematology doctor, and if relevant, your family will have the opportunity to also be tested and will need to sign a separate consent form. You will receive the same care even if you decide not to consent for the UK TTP Registry.

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:

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Do I have to take part?

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or decision not to take part, will not affect the standard of care you receive. 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?

We hope to understand more about TTP. As it is a rare disorder, the more sites in the UK treating TTP that are involved, more data can be collected. The information from this study may help us to increase our understanding and improve future treatment for patients with TTP.

What if new information becomes available?

Sometimes during the course of a research project, new information becomes available from the data or about treatments/drug that are being studied. If this happens, your research doctor will tell you about it during regular outpatient consultations.

Compensation arrangements

You will receive reimbursement for travelling expenses for any visit that is required specifically for the purposes of taking part in this Registry. We do not anticipate that this will be the case as the blood tests are considered to occur as part of your routine care, but occasionally an extra visit maybe scheduled for you. 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 you 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

All patients who agree to participate in the study must agree to their 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. You will be allocated a specific study identification number when you are enrolled in this trial and this will be used to identify you 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 independent group of people, called Research Ethics Committee (REC) to protect your safety, rights, wellbeing and dignity. This study has been reviewed and given favourable ethics opinion by Lewisham Research Ethics Committee (now known as South East London REC 5).

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

PIS UK TTP Registry, Version 6.0, 9th July 2013

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