What is the EPR Trial?

Why is this research being done?

This research study is being performed to see if trauma victims who have suffered a cardiac arrest due to bleeding can survive by cooling their body to preserve organ function. Previous studies have shown that cooling could protect vital organs until the surgeons have time to stop the bleeding and restore normal blood volume.

This procedure would only be performed when all other traditional treatments and resuscitation options were unsuccessful. If the cooling procedure is not done on these patients, the risk of death is 100%.

What will happen during the study?

In order to rapidly cool the patient, ice-cold saline (salt water) is pumped into the person through an IV. Once the body’s temperature is less than 10 degrees Celsius, the person is taken to the operating room where surgeons try to stop the bleeding and repair the injuries. A machine is then used to restore blood flow to the whole body and rewarm the person..

All the devices and fluids used in this study are approved for use in humans by the U.S. Food and Drug Administration, although not specifically for this type of cooling.

The study will enroll 10 qualifying persons to undergo the cooling procedure and cardiopulmonary bypass and 10 control patients who will undergo standard care will be enrolled.

Research staff will visit the patient in the hospital and collect information from medical records to find out the course of the patient’s hospital stay and the treatments received while in the hospital. The purpose of collecting this information is to better understand how the patient is doing with this treatment. This information may include time spent in the hospital and the type of care provided and other factors about the patient.

Visits by the research team in the hospital will happen approximately 28 days, 6 months and 12 months after the injury. If a patient has left the hospital, they will be asked to return to the clinic for a short visit. If unable to visit the clinic, the research team will contact the patient by telephone. Questions asked will be about how the patient is recovering and overall health status. This includes any changes in health and if a return to the hospital has been necessary.

This procedure would only be performed when all other traditional treatments and resuscitation options were unsuccessful. If the cooling procedure is not done on these patients, the risk of death is 100%.

What are the potential benefits of taking part in the study?

Patients may have a greater chance of survival by undergoing the cooling procedure. Because the results of this study may be used to develop new treatments in the future, other seriously injured patients may have a greater chance of survival.

What are my responsibilities if I take part in this research?

As a participant in this study, patients will be asked to complete all procedures as described above. If a patient choses to withdraw from the study, they should contact the study doctor or study staff.

What if I don’t want to participate in this research?

We respect patient autonomy and understand that this is not a measure every individual would want. Opting-out of the study is easy. Please see the section below titled “Opting-Out of the EPR Trial” for more details.

What are the risks of taking part in the study?

While participating in the study, the risks, side effects, and/or discomforts include:

•  Placement of the tubes needed for cold salt water and cardiopulmonary bypass can cause damage to the blood vessels.     Such injuries may require surgical repair. In very rare situations, these injuries could lead to the loss of a limb. Use of       cardiopulmonary bypass can cause a blood clot or air to enter the bloodstream. This could cause loss of blood flow to       an important organ or a limb.

•  Hypothermia (cooling) can cause problems with the normal clotting system, leading to bleeding complications. There       is also a low risk that these research procedures could allow a subject to survive with brain damage. These persons             would have otherwise died.

•  Other possible complications may include major bleeding, abnormal cardiac rhythms, fluid accumulation around the       heart, device malfunction, breakdown of red blood cells, lung, liver or kidney dysfunction, high blood pressure, major       infection, sepsis, heart attack, stroke, psychiatric episodes, blood clots, and wound break down.

•  Confidentiality: There is always a risk that a breach of confidentiality will occur. This is very unlikely, since all hard           copy data will be stored in a selected locked office and stored in secured, locked storage cabinets. Electronic data will       be stored in a password protected computer. Only designated members of the research team have access to the study       office and data storage equipment. All members of the research team are well trained in keeping confidentiality.

•  Effects on Pregnancy: The effects of research cooling (hypothermia) and cardiopulmonary bypass procedures on a             developing fetus are unknown. Therefore, known pregnant women were excluded from participation in these research     procedures. However, it is  possible that a woman may find out she is pregnant after these research procedures were         performed. If during the hospital stay a woman is found to be pregnant, the research team will follow the patient               through the pregnancy. The research team will not play any part in the decisions made about the pregnancy.

Opting-Out of the EPR Trial

To opt out of the Emergency Preservation and Resuscitation (EPR) Trial, please visit the front desk of the Trauma Department at John H. Stroger, Jr. Hospital of Cook County to obtain a “Do Not EPR” bracelet.

John H. Stroger Hospital of Cook County,
Trauma Department
1969 Ogden Ave.,
Chicago, IL 60612

If you are unable to pick up an opt-out bracelet in person, please send us an correo electrónico and one can be mailed to you. 

For questions or additional information, please email Mersaydes Young, Cook County Health trauma administrative analyst, at Mersaydes.young@cookcountyhhs.org.

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