PROPOLIS Study Resources for Patients
In this study, we propose to use pathogen-reduced plasma (PRP), an FDA-approved blood component that has undergone special treatment to reduce the risk of disease transmission as part of the resuscitation plan in the initial 24 hours of treatment.
We aim to:
1) reduce the amount of fluid given during the first 24 hours after a burn
2) reduce the incidence of lung injury and other complications related to the administration of fluids
3) determine if the blood product has any effect on inflammation.
An overall decrease in the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.
|Voluntary Participation||You do not have to take part in this research. It is your decision. You can also choose to stop participating at any time during the study.|
|Purpose||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.|
|Duration||Admission to six months post discharge from hospital.|
Like flipping a coin, you will be randomized into one of two groups.
· 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 a as part of fluid resuscitation during the first 24 hours after injury.
· Blood will be drawn at study enrollment, 12, 24, and 48 hours after injury and will be analyzed for markers.
· Information from your medical record will be collected hourly up to 48 hours in the burn center at 72 hours, and on a weekly basis until you are discharged from the hospital will be reviewed by study team.
· 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.
Risks include edema formation in the tissues, which may cause injury to vital organs, especially the lungs and kidneys, and even in death.
· The resuscitation products used in the study are approved for this purpose by the Food and Drug Administration. The experimental part of the study is to compare them.
· 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.
|Benefits||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.|
|Payment||You will not be paid for your participation in this study.|