Consent Form
Spinal Fluid Drainage in Subarachnoid Bleed
Patient Identification number[ ]
I have read the attached Patient Information Sheet
I have had the opportunity to ask questions and have received answers to my satisfaction
I understand that I may not gain any personal benefit from participation in this study
The additional risk to me above that covered in the consent for my operation has been explained
to my satisfaction
I understand that all information relating to my case will be stored within a secure database and
that if presented or published all personal details will be withheld
I understand that I may withdraw my consent at any time without affecting my routine treatment
or legal rights
I understand that that cerebrospinal fluid and venous blood that is removed as part of this study
may be stored anonymously for further biochemical analysis and disposed of accordingly
SignedDate
I confirm that I have explained the purpose of the study and am satisfied that the patient has an adequate understanding of the study
SignedDate
The Leeds Teaching Hospitals NHS Trust
Patient Information Sheet
Spinal Fluid Drainage in Subarachnoid Bleed
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 the time to read the following information carefully and discuss it with friends, relatives and your GP 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.
Background and Purpose of the Study
We are trying to find out whether drainage of spinal fluid results in better outcome for patients with subarachnoid haemorrhage. There is evidence to show from a previous study that inserting a spinal drain following subarachnoid haemorrhage has reduced the complication rate following this type of haemorrhage. The main complication is a process called vasospasm which is serious and poorly understood. It is associated with neurological deterioration and disability. There is evidence that spinal drainage may reduce the chance of this occurring. However, this has yet to be proven with a detailed and effective study like this one we are performing.
Why have I been chosen?
We hope to include all suitable patients with subarachnoid haemorrhage in the Neurosurgery Department in Leeds.
Do I have to take part?
Participation is entirely voluntary, you may withdraw from the study at any time without having to give reasons and your routine hospital care and legal rights will not be affected. If you decide to take part you will be given this information sheet to keep and will be asked to sign a consent form.
What will happen to me if I take part
If you decide to take part, we will place you into one of two groups (called group 1 or group 2). If placed in group 1, you will be given normal therapy and treatment. Normal treatment consists of keeping you on a special ward where there are many nurses available to look after you. We will place a small plastic tube into your vein (called a cannula) in order to give you fluid therapy directly into your blood. This will ensure you receive adequate amounts of water and salt. We will take regular blood tests (possibly daily) to keep a close eye on salt levels in your blood. You will be given tablets every 4 hours to help your brain cope with this haemorrhage. We may feel the need to place further small tubes (similar to the cannula in your vein) in your neck and wrist to help monitor you closely.
If we decided to place you in group 2, you will receive all the standard therapy described above in addition to a spinal drainage tube which we place in your lower back. This will be attached to a bag to collect spinal fluid. This may stay in your back for 1-2 weeks. This procedure is carried out under local anaesthetic and although application of this local anaesthetic may be slightly uncomfortable, the procedure should be painless. You will be asked to turn to your side with your legs curled up. Your lower back will be cleaned with disinfectant and a small needle will be used to inject some local anaesthetic. The procedure should take no longer than twenty to thirty minutes. Once the drain is inserted, you will be allowed to move as your condition allows.
The way we decide which group you will be placed in is on a random basis. This is like tossing a coin to decide the group. If it lands on heads, you will be placed in group 1 and if it lands on tails, you will be placed in group 2. Another way to understand this is to think of a roulette wheel. If the ball lands on red, you are put in group 1 and if the ball lands on black, you are put in group 2. This means there is an equal chance that you will be placed in either group 1 or group 2. This method ensures that the study is scientifically accurate.
Are there any benefits from taking part?
There may be no benefit to you from participation in this study. We are investigating whether or not spinal drainage does improve the patient’s outcome following subarachnoid haemorrhage.
Are there any risks?
There is a very small risk of infection in the spinal fluid (we estimate this to be less than one percent). Although this complication is not often seen, we treat it very seriously. We will continually assess for signs of infection including inspection of the drain site and sending spinal fluid samples to the laboratory to look for infection. We collect this from the draining bag and so it will not require any further needles or injections. If there is any sign of infection we will remove the drain and treat appropriately (with antibiotics if necessary).
Will my taking part in this study be kept confidential?
All information collected in the study is confidential. You will not be able to be identified at any time including during presentation or publication of the study results.
What will happen to the results of the study?
We hope to publish the results in a medical journal. You will not be able to be identified from published results.
Who is organizing and funding the research?
The Neurosurgical Department at Leeds General Infirmary.
Who has reviewed the study?
The study has been reviewed by the Leeds (West) Research Ethics Committee.
Contact for further information
Mr Yahia Al-Tamimi (Lead Investigator)
Neurosurgery Dept, Leeds General Infirmary
Mr Stuart Ross (Consultant Neurosurgeon)
Neurosurgery Dept, Leeds General Infirmary
Thank you for your participation
Date:Number: