PREEVEnT

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A randomization process (like flipping a coin) is used to decide if the patient will get plasma or usual care. Usual care typically includes salt water and/or a protein mixture. Researchers will compare the two groups to see if one group gets better sooner than the other.

The study is “open label” which means everyone will know the patient’s treatment. Researchers will collect information from medical records and may collect a small amount of blood at two timepoints as part of the study.

Who will be included?

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

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

Why this research?

Trauma, burns included, is the leading cause of death and researchers think that giving a commonly used product earlier than usual could help chances of survival.

Why plasma?

When someone suffers from a heat 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 thin layer of cells lining blood vessels. This layer is important because it keeps fluids inside the blood vessels and controls inflammation. When this layer is damaged, blood vessels become leaky, causing even more fluid to escape into the body. This leads to swelling and can make the patient even sicker. Plasma has proteins that help fix the blood vessel lining, which may lower the amount of damage and help the body recover.

Bad burns can cause inflammation, the body’s natural response to injury. While some inflammation is needed for healing, too much inflammation or for too long can be dangerous. It can spread throughout the body, putting stress on organs like the heart, lungs, and kidneys. If it goes unchecked, this can lead to organ damage or even organ failure. Plasma may help by giving proteins that lower inflammation.

Plasma plays a key role in blood clotting. Since bad burns can make it harder for the body to form clots properly, giving plasma gives the needed clotting factors to stop a patient from bleeding too much.

Finally, plasma helps protect burn patients from infections by giving antibodies that fight off harmful bacteria and viruses. It also contains important nutrients and proteins that help with tissue repair, helping burns heal better.

What are the risks? Are there any benefits?

Patients who have bad burn injuries often get plasma later in the course of care. Researchers do not believe that there is any more risk to getting plasma earlier than usual. The research could provide information that saves lives.

How are people enrolled in the study?

People who have heat burn injuries who go to a research site participating in PREEVEnT may be included in this study.

Normally, researchers must ask a person for their permission (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/.

How do I opt out of the study?

You can opt-out of the study by reaching us using any of the methods below and letting us know that you do not want to participate. Please make sure to give us your name and contact information so that we can get in touch with you. We can provide you with a hypoallergenic silicone bracelet to wear that says that you should not be enrolled into the study. Please note that opting out of the study only means that you will not get plasma as part of the study. Opting out will not keep you from getting plasma as part of your normal care.