Emergency Preservation and Resuscitation (EPR) 

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.

 

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 page titled "Opting-out" for more detail or send us an email.

 

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.

 

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• 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.

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