Critical Care . Resucitation . Airway . Shock . Hemorrhage ( C2RASH )

The “Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury” trial, or PREEVEnT, is a study that will look at whether giving plasma earlier will increase survival for someone who suffered a severe thermal burn. Plasma is widely used across the country, but usually later in a patient’s care. Researchers think that giving plasma closer to the time of severe burn injuries could save lives.

Typically, patients who have suffered a large burn will lose a lot of fluid when their skin, which acts as a barrier, is damaged. This can lead to a person’s blood pressure dropping dangerously low, which could cause shock. Plasma, which is the liquid part of blood, can be used to keep fluids stable. 

Burns can also damage the lining of your blood vessels, the endothelium. This layer’s main job is to keep fluids inside the blood vessels and control inflammation. While some inflammation is necessary for healing, prolonged or excessive inflammation can be dangerous. It can spread throughout the body, putting stress on organs like the heart, kidneys, and lungs. Plasma helps regulate this response by providing essential proteins that control inflammation and keep it from spiraling out of control.

In PREEVEnT, patients may be given plasma shortly after arriving at the hospital. Regardless of what patients receive for this study, patients can still get plasma later in their care if they need it.

A randomization process (like flipping a coin) is used to determine if the patient will receive plasma or usual care. Every burn center has their own protocol for treating patients who arrive with serious burn injuries. If you are randomized to the usual care arm, you will receive other types of fluid therapy such as salt water and/or a protein solution called albumin.  

The study is “open label” which means the medical team and patient will know what is being given. For this study, researchers will compare these groups to see if one group recovers from their injuries better than the other. Researchers may do a blood test and will collect information from medical records as part of the study.

PREEVEnT will enroll adults who are 18 to 75 years old and who are:

• Severely burned with a thermal injury that covers more than 20% of their body.
• Being admitted into a burn center or burn ICU that is participating in PREEVEnT.

Trauma, burns included, is the leading cause of death and researchers think that providing a commonly used product earlier than typical care could improve chances of survival.

When someone suffers a severe burn, their body loses a lot of fluid because the skin, which normally acts as a barrier, is damaged. This fluid loss can cause blood pressure to drop dangerously low, putting the patient at risk for shock. To help, doctors often give plasma, the liquid part of blood, to replace lost fluids and keep circulation stable.

Burn injuries also damage the endothelium, the thin layer of cells lining blood vessels. This layer is crucial because it keeps fluids inside the blood vessels and controls inflammation. When the endothelium is damaged, blood vessels become leaky, causing even more fluid to escape into the tissues. This leads to swelling and can make the patient even sicker. Plasma contains proteins that help repair the endothelium, reducing further damage and helping the body recover.

Another major issue with burns is inflammation, the body's natural response to injury. While some inflammation is necessary for healing, prolonged or excessive inflammation can be dangerous. It can spread throughout the body, putting stress on organs like the heart, lungs, and kidneys. If it goes unchecked, this widespread inflammation can lead to organ damage or even organ failure. Plasma helps regulate the body’s response by providing essential proteins that control inflammation and keep it from spiraling out of control.

Plasma also plays a key role in blood clotting, which is often disrupted in burn patients. Since severe burns can make it harder for the body to form clots properly, plasma transfusions provide the necessary clotting factors to prevent excessive bleeding.

Finally, plasma helps protect burn patients from infections by supplying antibodies that fight off harmful bacteria and viruses. It also delivers essential nutrients and proteins that promote tissue repair, helping burns heal more effectively.

Overall, plasma is a vital tool in burn treatment; plasma stabilizes circulation, protects blood vessels, controls inflammation, prevents organ failure, helps with clotting, and supports healing.

Patients who have suffered a burn injury often receive plasma later in the course of care. Researchers do not believe that there is any increased risk to providing plasma earlier in the course of care.  The research could provide information that saves lives.

People who have thermal burn injuries who are being admitted to a research site participating in PREEVEnT may be included in this study.

Normally, researchers must ask a person for their consent before they can be in a study. Because burn injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses, and having time to think about whether to join. A person with a burn injury is often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of burn injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception from Informed Consent, or EFIC. Once the enrolled person is better and can consent or their family arrives at the hospital, the researchers will ask for consent to continue with the study. For more information regarding EFIC, please visit https://www.litesnetwork.org/projects/emergency-research/.