FAR Research Study
Severe bleeding is when someone loses a lot of blood. Without proper treatment, severe bleeding can cause death. We are doing a research study to learn the best way to treat patients in the emergency room with severe bleeding.
The FAR Study is a research study that will look at 2 ways for treating patients with severe bleeding in the emergency room. The goal of this study is to help improve outcomes and reduce the need for blood transfusions in patients with severe bleeding. Your participation will help researchers learn the most effective way to help patients and improve their care.
Who can participate in this study?
To participate in this study, patients must be at least 18 years old and be at high risk for severe life-threatening bleeding after an injury. If you meet the criteria and have not opted out of the research study, you will be randomly entered either into group 1 or group 2. You may not know which group you are in.
- Group 1: Patients are treated with the standard initial IV fluids that are similar to salt water, for the treatment of trauma with bleeding.
- Group 2: Patients are treated with an initial IV fluid therapy for the treatment of trauma with bleeding that contains a factor important in bleeding control and is more similar to normal circulating blood.
I don’t want to participate in this research study:
You do not have to participate in this research study. You can agree to be in this study now and change your mind later. Your decision will not affect your routine care or how you are treated. Your health care team’s attitude toward you will not change.
Email us at FAR@MaineHealth.org with the subject line 'FAR Declined.' We will give you a medical alert bracelet with the words ' FAR Declined.' You will need to wear the medical alert bracelet at all times during the study period (about 2 years). Please include your birthdate, full legal name, and address so we can mail you a bracelet. We will put your personal information into a secure encrypted database. The Trauma Surgeon will use the database to verify that you declined to participate in the FAR study just in case you lose the FAR Decline bracelet. All personal information will not be shared and will be stored in a secure database for the length of the study.
Most research studies require permission (consent) before someone is included in a study. However, someone who comes to the emergency room with severe bleeding following injury may not be able to give consent right away.
Severe bleeding needs to be treated and cared for right away, so the treatment being studied will need to be started immediately. There may not be enough time to find the patient's loved ones and ask about the study. A patient may be included in this study before they can give their consent to be part of it. As soon as possible, we will ask the patient for permission. If the patient‘s condition does not permit the patient's consent then we will find the patient’s loved one or Legal Authorized Representative and will ask if the patient can continue in the study.