PROPOLIS (Plasma Resuscitation Without Lung Injury) StudyCLOTT 3
More than 450,000 people suffer a burn each year in the United States, resulting in 40,000 hospitalizations. On the battlefield, 10% of the injured service members are burned. Resuscitation of patients with extensive burns is a significant challenge requiring massive amounts of fluid, typically a type of salt water that is given by vein (i.v.). This treatment is needed in order to restore circulating blood volume, but it also leads to swelling in the tissues that may cause injury to vital organs, especially the lungs and kidneys, and even death.
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:
- reduce the amount of fluid given during the first 24 hours after a burn,
- reduce the incidence of lung injury and other complications related to the administration of fluids, and
- 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.
This highly innovative project has important clinical implications for care of the burned patient. Adjuncts to resuscitation therapy that reduce lung injury and multi-organ failure, correct inflammation, and decrease overall fluid needs would provide valuable clinical benefit, including reduced death, shorter intensive care unit stay, decreased hospital costs, and improved outcomes.
This study will be conducted over three years. It is registered as a clinical trial at clinicaltrails.gov; Identifier: NCT04681638. This work is supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through Defense Medical Research and Development Program, Joint Program Committee 6 (JPC-6)/CCCRP Multi-Domain Lifesaving Trauma Innovations (MuLTI) Award under Award No. W81XWH2020032.
If fluid administration therapy including this blood product reduces lung injury, and ultimately death from burns, it would potentially save over 6,400 patients a year. Any reduction in the number of burn patients who die from burn shock would be a huge improvement.