Field Trial of Hypotensive Resuscitation versus Standard Resuscitation in Patients with Hemorrhagic Shock after Trauma, A Pilot

Trauma is the leading cause of death for people between the ages of 1 and 44 years. Approximately 80% of trauma patients who die do so from severe brain injury, severe bleeding or a combination of the two. Over 50% of trauma deaths occur in the first 12 hours after injury and the most common cause of unnecessary death after trauma is severe bleeding.

The first priority of medical treatment is to help the body make blood clots that stop the bleeding. Paramedics use measures to help clots form such as applying direct pressure to a surface wound or applying a tourniquet (an elastic cord used to compress blood vessels when tightened by twisting) above a wound on an arm or leg. If the bleeding is inside the chest, abdomen (belly), or pelvic (lower belly) area, surgery performed in a hospital may be the only effective method to stop the bleeding. An injured person at risk for bleeding that cannot be stopped by direct pressure or a tourniquet needs to be taken to a hospital as soon as possible.

If the amount of blood lost is too large, vital organs such as the brain, heart, lungs, and kidneys will not receive the blood they need to function properly. To help support the blood flowing to these vital organs, a special fluid called normal saline (0.9% sodium chloride injection) is routinely given through a tube into a blood vessel. Paramedics give normal saline to an injured person while the person is being safely removed from the scene and taken to the nearest hospital.

Although restoring blood flow to vital organs is critical to survival, giving normal saline to the injured person raises the pressure inside the blood vessel, which may move clots and increase bleeding. It has not yet been determined what amount of normal saline is best to support blood flow while avoiding moving newly formed clots during the time the person is being taken to the hospital.

The purpose of this study is to determine if severely injured people do better when they are given small amounts of normal saline or if they do better when they are given large amounts of normal saline. Currently, giving large amounts of normal saline is the normal treatment.

This study will enroll 200 subjects across the United States and Canada. The study will enroll approximately 30 subjects here in the Portland/Vancouver area. Half will receive the traditional large amounts of fluid, and half will receive the experimental small amounts of fluid.

Consent Information

Normally, before someone joins a research study, it is discussed with him or her in detail. Also, a consent form that lists the purposes of the study, the possible benefits, and the risks from being in the study is reviewed with the person. If the person agrees to join the study, the consent form is signed. In most cases, this takes place before any study procedures are done or treatment is given. This process is called "informed consent" and ensures that the person volunteered for the research study only after being given the information necessary to make an informed decision.

For this study, investigators will not be able to get written informed consent from each study participant, due to them being unconscious while in cardiac arrest. Instead, the investigators will try to inform the community about the study and address any concerns or questions before the study is approved to begin. We will do this by:

• This website
• Community meetings
• Online and mailed surveys
• Newspapers and Newsletters

People will be given the choice to refuse being in the study by contacting the investigators at OHSU and asking to opt-out.