PROPOLIS FAQ’s
Why is this research being done?
The purpose of this research is to better understand why some patients develop acute lung injury after being severely burned and others do not. It might be that there are certain resuscitation treatments and blood products reduce the likelihood of acute lung injury.
What happens to me if I agree to take part in this research?
If you consent to take part in this study, you will be put into a study group by chance (like a coin toss/ like drawingstraws). You have a 1 out of 2 chance of being placed in each group. You cannot choose your study group. Participants in one group will receive lactated ringers as part of fluid resuscitation during the first 24 hours after injury. Participants in the other group will receive pathogen-reduced plasma as part of fluid resuscitation during the first 24 hours after injury.
Both fluids are approved by the Food and Drug Administration (FDA) for resuscitation after injury. Resuscitation for both groups will be monitored by a Burn Navigator every hour to be sure that the participants are receiving the right amount of fluids. The Burn Navigator is approved by the FDA for guiding resuscitation.
During the study, small amounts of blood will be drawn (taken from the catheters that are already in your artery or veins) and will be tested for markers that may predict who will develop acute lung injury. The amount of blood taken each time (at study enrollment, 12, 24, and 48 hours after injury) is a very small amount (about 2 teaspoons each time, totaling 2.5 tablespoons).
The study team will collect information from your medical record hourly up to 48 hours in the burn center and at 72 hours, and on a weekly basis until you are discharged from the hospital. However, no additional procedures will occur for this study after the first 48 hours. Before your discharge, study staff will ask you for contact information (phone, address and email) for you and for a person who could help us contact you.
After your discharge, study staff will contact you at six months and ask you to take a short survey about how your recovery is progressing. The survey is called the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10. It has 10 questions that will measure your health and functioning. The research staff will try to reach you by phone, email and regular mail.
The blood drawn during the study will be analyzed for markers.
Could being in this research hurt me?
The resuscitation products used in the study are approved for this purpose by the Food and Drug Administration. There may be risks associated with either arm of the study. Based on available data, patients in the crystalloid arm may be at higher risk for volume overload (infusion of a large volume of fluid during the resuscitation phase of care), to include acute respiratory distress syndrome (ARDS). Patients in the plasma arm may be at higher risk of transfusion-related complications such as TRALI (transfusion-related acute lung injury). In brief, both groups of patients may be at risk of lung injury. It is not possible to determine which group is at higher risk; ascertaining this risk is a major aim of the study.
There is a very small risk of disease transmission in the plasma arm.
All blood draws will be taken from catheters already in your artery or veins that were placed as part of the treatment for your injuries. The amount of blood taken out of your body for this study amounts to two tablespoons, which will be of no consequence to your health and recovery.
There is a small risk that a breach of confidentiality could occur; however, every member of the research team is trained on maintaining research records and your confidentiality. We will keep records on password-protected computers and restrict access to your records to make sure this doesn’t happen. We will also remove your name and all other identifiable information from your study data as soon as we can.
There may be unknown risks.
Will being in this research benefit me?
There is intent to benefit all participants of this study regardless of randomization group. Possible benefits to you include lower complications related to fluid resuscitation.
What happens if I agree to be in this research, but I change my mind later?
If you decide to leave this research, you are being asked to contact the research team so that the investigator can stop collecting your data and blood samples.
Will I be paid for taking part in this research?
You will not be paid for your participation in this study.
What is different about the plasma being used for this study?
Pathogen-reduced plasma is created using a special machine that makes viruses, bacteria, and parasites inactive, reducing infections that patients can get from transfusion. Regular plasma undergoes bacterial testing, but this method provides reduced risk from pathogens that we may not even have tests for yet.
