PATIENT INFORMATION SHEET KEY FACTS

Transcription

1 PATIENT INFORMATION SHEET KEY FACTS Please read this carefully and refer to the full information sheet You are invited to take part in a research study, comparing subcutaneously (injection under skin) administered Kineret to standard treatment in patients who have had a subarachnoid haemorrhage. The study is being carried out by Dr Pippa Tyrrell, Consultant in Stroke Medicine together with your consultant and members of the research staff. If you consent to take part in the study you will:- o have a baseline assessment to confirm that you are eligible to take part in the study; this will be in addition to your standard care o be randomised to receive, either twice daily injections of Kineret as well as standard treatment or standard treatment and no study drug These will be for up to 21 days from the onset of the haemorrhage (or until discharge from hospital) o All patients will have samples of blood taken at pre-determined time points for up to 21 days (or discharge). These samples will be in addition to standard care o All patients will have assessments of their health at pre-determined time points for up to 21 days (or discharge). These will be in addition to standard care. Members of the research team will have access to your medical records during and after study participation. You will not benefit directly from taking part in the study and potential risks are explained You do not have to take part if you do not want to. You are free to withdraw from the study at any time and this will not affect the care you receive. We ask permission to keep blood samples for an indefinite period of time following the end of the study Please refer to full information sheet Thank you for your time Patient information sheet, Version 2 28/7/11 Page 1 of 9

2 Brain Injury Research Group Clinical Sciences Building, Salford Royal Foundation Trust, Stott Lane, Salford, M6 8HD Dr Pippa Tyrrell Mr Andrew King Mr James Galea Sharon Hulme Senior Lecturer in Stroke Medicine Consultant Neurosurgeon NIHR Fellow in Neurosurgery Research Nurse Telephone: Telephone: Telephone: An open-labelled study of the effect of subcutaneous, interleukin-1 receptor antagonist (Kineret ) on levels of inflammation following subarachnoid haemorrhage Short title: SC IL-1RA in SAH. REC Ref: 11/NW/0390 You are invited to take part in a study investigating how a potential treatment for brain injury works and acts in the body. You need to understand why the study is being done and what it will involve. Please take time to read this information. Talk to others about the study if you wish. The information sheet is divided into two parts: Part 1 why is the study being done and how will it affect you. Part 2 information in more detail. Please ask if you need more information. Take time to decide whether or not you wish to take part. What is the purpose of the study? After a subarachnoid haemorrhage (SAH) blood flow to the brain may be reduced, preventing oxygen from reaching brain tissue resulting in damage. This is known as cerebral ischaemia. Reduced blood flow may trigger symptoms similar to a stroke, which can be temporary or lead to long term disability. There are currently no treatments to reverse damage caused by cerebral ischaemia. We know that levels of inflammation within the body can influence the degree of cerebral ischaemia. Our research group has extensively investigated the use of a well-established anti-inflammatory drug Kineret in patients with brain haemorrhage. Kineret is similar to a naturally-produced protein, called interleukin-1 receptor antagonist (IL- 1Ra) and is already licensed to treat patients with rheumatoid arthritis. We have evidence from previous studies that Kineret reduces levels of inflammation in the body after SAH when given as a high dose infusion into a vein (intravenous). Kineret given at these levels are designed to treat any potential brain injury caused by cerebral ischaemia and in order to develop Kineret as a potential preventative therapy; we need to know its effect on levels of inflammation when given subcutaneously (injected into the skin) and using lower doses over a longer period of time. Patient information sheet, Version 2 28/7/11 Page 2 of 9

3 In order to do this, we plan to compare levels of inflammation in the blood of participants who have received subcutaneous injections of Kineret with those who have not. Why have I been asked to take part? You have suffered a subarachnoid haemorrhage (SAH). You are currently receiving medication to improve blood flow to your brain. However, this may not prevent cerebral ischaemia. Cerebral ischaemia leads to a risk of developing symptoms similar to a stroke e.g. limb weakness or difficulty with speech, so you will remain under the care of the neurosurgical team until you are discharged from hospital. We would like to conduct an assessment and obtain a blood sample each day for up to 21 days from onset of your symptoms (or earlier if you are discharged from hospital). You will also be randomised to receive either standard treatment plus Kineret twice-daily as a subcutaneous injection or standard treatment with no study drug. What is Kineret and how does it work? Kineret (approved name Anakinra) reduces inflammation in the injured brain. It has been given to thousands of patients with rheumatoid arthritis, to healthy volunteers and, in previous studies undertaken by our research group, to patients with SAH and stroke. Do I have to take part? No, you do not have to take part in this study. If you decide that you want to take part you will be given this information to keep and asked to sign a consent form. You are free to withdraw from the study at any time. You do not have to give a reason for doing so and this will not affect the care you receive. What will happen if I decide to take part? Members of the research team will perform an assessment to check that you are eligible to participate in the study and then will ask for your consent to participation. The research team will then contact an independent randomisation service for allocation of your study group. What is randomisation? Sometimes we don t know which way of treating patients is best. To find out, we need to compare different treatments. We put people into groups and give each group a different treatment and the results are compared. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly). This selection will be done by a third-party (external service) so which group you are in will not be influenced by you or the researcher. In this study only half the participants will receive Kineret along with standard treatment, the others will receive standard treatment only. Patient information sheet, Version 2 28/7/11 Page 3 of 9

4 After you have been randomised, a sample of up to 20mls of blood (up to 4 teaspoons) will be taken to establish levels of inflammation within the blood. Some of this blood will be used for standard clinical investigations and where possible we will try to take research and clinical samples at the same time. If you have been randomised to receive Kineret, you will then be given twice daily injections (usually 7am and 7pm) for up to 21 days from the date of your SAH or until you are discharged from hospital. The research staff will also take samples of blood once a day over the same time period. You will also be assessed and observed carefully. If you are not randomised to receive Kineret, you will have only assessments and blood samples. Whenever possible, the blood will be taken from lines which are already in place as part of your routine care. The assessment on day of discharge (or day 21 after SAH) will record everything that has happened since you received Kineret as well as your current condition. You will be given a discharge pack containing contact details for the study team and a sheet in which to record any concerns you may have after discharge. You will be contacted by the research team 30 days from the date of your haemorrhage to discuss these issues and again at six months to record your progress and recovery. With your permission, we would like to contact your family doctor (GP), Consultant and any other Health Care Professional involved in your care to let them know that you have been a volunteer. We may also ask them for medical information about you. Are there any alternative treatments? No, there are no current alternative treatments. What are the possible benefits of taking part? The study will not have any direct benefits to you but you will be helping to increase what is known about subarachnoid haemorrhage and the development of new treatments. What are the possible risks/side effects of taking part? Your well being and safety is our first concern. Most of the information about the side effects of Kineret has been discovered from the treatment of patients with rheumatoid arthritis; many of whom have taken Kineret for a long time (months or years). The intervention period for this study is much shorter (maximum of 21 days). In studies that have given Kineret over short periods (for severe infections; subarachnoid haemorrhage or stroke) there has been no evidence of increased infections however, studies in patients with rheumatoid arthritis who have been on long term Kineret have shown a small possibility of an increased risk of infections; some of which are classed as serious. Patient information sheet, Version 2 28/7/11 Page 4 of 9

5 Previous studies also showed that after long-term use of Kineret the body may make antibodies to IL-1Ra (found in Kineret) with a possible risk of allergy. This is a rare but a potentially serious side effect. If you think you may have received Kineret or Anakinra, or a similar drug either as part of your general care or as part of another research study, you may be excluded from taking part in this study. The researcher will be happy to discuss this issue. Headache and nausea are common side effects of subarachnoid haemorrhage. They have also been reported after Kineret by patients with rheumatoid arthritis. Medications to alleviate headache and nausea are already part of your standard care. You may experience some discomfort and bruising caused by blood sampling, when existing lines are not available. We will try to combine clinical and research blood sampling to minimise your discomfort. We do not anticipate any side effects from this study, but if any adverse effects are seen the study intervention will be stopped immediately. Withdrawal from the study If you, your representative, or the doctors responsible for your clinical care choose to withdraw you from the study after receiving Kineret, you will be asked if the research team can complete an end of study assessment. If possible a final sample of blood will be taken. We will continue to monitor your progress using information obtained as part of standard clinical care and no further samples will be taken. The study team may withdraw participants if they consider it to be in their best interests. Pregnancy The effects of Kineret on the foetus and nursing child are not known. If you suspect or know you are pregnant or are breast-feeding you cannot take part in the study. Will I be paid for taking part? You will not receive payment for taking part in the study. Researchers working on the study are funded by the Medical Research Council or the University of Manchester and will receive no extra remuneration as a result of your participation. THIS COMPLETES PART 1 OF THE INFORMATION SHEET Patient information sheet, Version 2 28/7/11 Page 5 of 9

6 PART 2 What if new information becomes available? Sometimes during the course of a project, new information becomes available relating to what is being studied. If this happens, a researcher will tell you about it and discuss if you want to continue in the study. You may be asked to confirm your willingness to continue by signing a new consent form. What if there is a problem? This is very unlikely. In the event that something does go wrong and you are harmed there are no special compensation arrangements. If this is due to someone s negligence you may have grounds for a legal action for compensation against Salford Royal Foundation NHS Trust but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you. The study is being conducted by members of staff from the University of Manchester and will be covered by their institution s no fault compensation policy. Complaints. If you have concerns about any aspect of the study, you should speak to the researcher who will do their best to answer your question. Alternatively, you can contact Rachel Georgiou, Research and Development Directorate, Salford Royal NHS Foundation Hospital, 544 Eccles New Road, Salford, Tel Confidentiality. If you decide to take part your hospital notes and other health records may be seen by authorised people (other researchers and people checking the study conduct). Your name will not appear in any publications arising from the study. What will happen to the results of the study? The results of the study will be submitted for publication to medical journals and at conferences. The results will also be submitted to authorities within the United Kingdom who are responsible for the development of new drugs to ensure they have all relevant information about the study drug and the conduct of the study. If you wish, we can send you a summary of the study findings but this may not be for some time. Storage of blood samples and usage. With your permission we would like to treat the blood samples that you give as a gift to allow further investigation of subarachnoid haemorrhage, brain injury, inflammation, drug development and other related disorders; as well as checking the quality of our current tests and development of new ones. Patient information sheet, Version 2 28/7/11 Page 6 of 9

7 We would also like to be able to use remaining components of the sample given to check the quality of the tests we carry out and develop new tests. You are under no obligation for your samples to be used in this way. You will be asked to sign a consent form to allow your samples to be used for these purposes. Samples would only be used for research relating to brain injury, inflammation, drug development and other related disorders. You are under no obligation for your samples to be used in this way. You will be asked to sign a consent form to allow your samples to be used for the purposes stated above. Data storage and usage. The study will confirm the safety of giving Kineret as a subcutaneous injection to patients with subarachnoid haemorrhage, therefore if you decide to withdraw from the study we will need to keep the information that we have obtained from you already. In order to ensure we have an accurate record of your history and clinical presentation, we will also need to access your clinical records, regardless of whether you are randomised to receive Kineret. Anonymised data will also be shared by members of the research team based within the University of Manchester. All clinical information will be anonymised before it is stored. The study is funded by the Medical Research Council. As such we will be following the Council s guidelines regarding the sharing of study data. This means that the anonymised data from the study will be available to others. The data and information from the study will be stored for up to 20 years. Organisation of the study The study is organised by the Brain Injury Research Group at Salford Royal Foundation NHS Trust and The University of Manchester. Who has reviewed the study? The study has been reviewed by and has received a favourable opinion from North West 6 REC GM South Research Ethics Committee and approval from the Medicines and Healthcare Regulatory Agency. Contact for further information: If you have any queries or questions relating to the study please ask the unit staff to contact: Sharon Hulme, Senior Research Nurse, Tel: or study mobile: James Galea, Clinical Research Fellow, Thank you for your time. Patient information sheet, Version 2 28/7/11 Page 7 of 9

8 PARTICIPANT CONSENT REC Ref No: 11/NW/0390 Title of Project: An open-labelled study of the effect of subcutaneous, interleukin-1 receptor antagonist (Kineret ) on levels of inflammation following subarachnoid haemorrhage Name of Lead Investigator: Dr Pippa Tyrrell Please initial box I confirm that I have read the information sheet dated 28/7/11 (version 2) and have had the opportunity to ask questions I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. I understand that sections of any of my medical notes may be looked at by responsible individuals from The Brain Injury Research Group, Salford Royal NHS Foundation Trust or from regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. I understand that the research team may wish to contact my GP other health care providers to inform them of my participation in the study and also to ask for information about my health. I agree that they can do this. I understand that anonymised data from the study will be made available to others in accordance with Medical Research Council guidelines. I understand that should I choose to withdraw from the study, members of the research team may continue to monitor my progress using information from my clinical notes. I give permission for these individuals to access my records I agree to take part in the above study. Patient information sheet, Version 2 28/7/11 Page 8 of 9

9 Name of research subject Date Signature (Please print) Name of Witness to Signature Date Signature (Must not be a member of the research team) Please print Member of research team member Date Signature Please print SAMPLE STORAGE CONSENT I agree that the sample(s) I have given and the information gathered about me can be stored by Dr Steve Hopkins and The Brain Injury Research Group at The University of Manchester for use in possible future projects for an indefinite time period, as described in the attached information sheet. I understand that some of these projects may be carried out by researchers other than those currently working with The Brain Injury Research Group who ran the first project. I agree that any remaining components of the blood sample may be used in the future for research relating to brain injury, inflammation, drug development and other related disorders. It may also be used for laboratory quality control and development purposes. Please initial box Name of research subject Date Signature (Please print) Name of Witness to Signature Date Signature (Must not be a member of the research team) Please print Member of research team member Date Signature Please print 3 copies required: top copy for researcher; one copy for patient; one copy to be kept with research participants notes Do you wish to receive information about the results of this study? Yes/No please circle Patient information sheet, Version 2 28/7/11 Page 9 of 9