This hospital is taking part in a research study to find ways to reduce severe bleeding after serious injury. We are asking for your permission to enrol into a research study or continue study treatment

for ________________________________ (the participant).
You are being asked because the patient is unable to give consent.

WHAT YOU SHOULD KNOW ABOUT RESEARCH STUDIES:

This form gives information about the study including the aims, risks and benefits of taking part.

In this hospital, patients with severe bleeding are given the usual emergency treatment for bleeding. The aim of this research study is to find a better treatment. We hope that the study treatment (tranexamic acid) will help clotting and so lessen the amount of blood lost and reduce the need for a blood transfusion. But the study treatment may cause clots where they are not needed. We hope to find that the treatment will do a little more good than harm but we don't yet know this. Please read the information below carefully and ask the doctor looking after the participant any questions you have.

1) Why is this research being done?
Severe bleeding is a common cause of death after injury and it is important to find better ways of reducing the amount of blood lost.

2) What is the purpose of this study?
Tranexamic acid is often used to reduce bleeding after major surgery such as heart operations. This study is being done to see if it can also reduce bleeding after major injury. Tranexamic acid is not a new drug and is an approved treatment for many common conditions that involve bleeding.

3) Who is doing the study?

Dr ________________________ is in charge of this study at this hospital. The study is co-ordinated by doctors at the University of London.

4) A patient cannot be in this study if:

• he/she is known to be under 16
• he/she was injured more than 8 hours before arriving in hospital
• the doctor thinks there is a particular reason why tranexamic acid definitely should not be given
• the doctor thinks there is a particular reason why tranexamic acid definitely should be given

5) What will happen to the participant if you decide to allow him or her to be included in this study?
The participant was given all the usual emergency treatments for bleeding, including fluids to replace the blood that he/she lost. He/she was also given a dose of either the active tranexamic acid or an inactive dummy medicine called saline. The dose was given over a period of eight hours. The choice of what to give (active treatment or dummy treatment) was made randomly by a computer in the University of Oxford, UK. The doctors looking after the participant do not know whether he/she got the active or the dummy medicine. This information is kept on a confidential list in another hospital. The study involves no extra tests but the treating doctor will send brief details to the Co-ordinating Centre in London about how the participant has been. This information will be used in strict confidence by the people working on the study and will not be released under any circumstance.

6) What are the possible risks of being in the study?
Tranexamic acid is widely used and at the moment there is no conclusive evidence of serious side effects with short term use. Tranexamic acid is NOT a new drug.

7) What are the possible benefits of being in the study?
We hope that tranexamic acid may help reduce blood loss. The knowledge that we gain from this study will help people with similar injuries in the future.

8) If you have any questions or problems, who can you call?
If you have any questions you can contact

Dr ______________________________________________

by telephoning ____________________________________

9) What information do we keep private?
All information about the participant and his/her injury will be kept private. The only people allowed to look at the information will be the doctors who are running the study, the staff at the Co-ordinating Centre and the regulatory authorities who check that the study is being carried out correctly. We will publish the results of the study in a medical journal so that other doctors can benefit from the knowledge, but personal information will not be included and there will be no way that the participants can be identified.

10) Can the study end early for the participant?
The study treatment can be stopped at any time in the 8 hours if necessary. We hope that you will let us use information about how the participant got on, but if you do not want us to use it then please tell the treating doctor.

11) What else do you need to know?

• The study is funded by the University of London and the World Health Organisation, not the makers of tranexamic acid.
• If we find out any new information that might affect your decision to allow the participant to be enrolled in the study, we will give it to you.
• The London School of Hygiene & Tropical Medicine (University of London) as the Co-ordinating Centre for the study accepts responsibility attached to its sponsorship of the study and, as such, would be responsible for claims for any non-negligent harm suffered by anyone as a result of participating in this study.
• We will give you a copy of this consent form to keep.

12) Consent
I understand what the study is about and I am happy for this patient to be enrolled/continue participation in this study. I also agree that the details about the recovery of the participant named below can be used by the study.

Name of Participant _______________________________________________________

Name of Legal Representative _______________________________________________

Signature of Representative ________________________________________________

Date ____________________________________________________________________

Address of Representative __________________________________________________

Telephone number ________________________________________________________

Relationship to Participant __________________________________________________

Name of doctor requesting consent __________________________________________

STUDY CO-ORDINATING CENTRE:
International Study of Bleeding After Injury
Room 180
London School of Hygiene & Tropical Medicine
Keppel Street
London WC1E 7HT

Tel 020 7299 4684
WWW.CRASH2.LSHTM.AC.UK