NCT04681638

Plasma Resuscitation Without Lung Injury

Plasma Resuscitation withOut Lung Injury

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Coalition for National Trauma Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The treatment of patients with major burns requires resuscitation with massive amounts of fluid, typically a type of salt water that is given by vein. This frequently results in injury to vital organs, especially the lungs and kidneys, and even in death. In this study, the investigators propose to use plasma, a specially prepared blood product made from the liquid part of blood, that has undergone special treatment to reduce the risk of disease transmission. The aims include 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 funds and 3) determine if the blood product has any effect on inflammation. An overall decrease the amount of fluids that burn patients receive should decrease the potential for lung injury, decrease days in the hospital, and improve survival.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Pathogen-Reduced Plasma	The treatment group will receive an additional infusion of Pathogen-Reduced Plasma based on the formula, hourly rate, mL/hr = (1 mL\*kg\*TBSA)/24 hr. This infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
DRUG	Crystalloid Solutions	The control group will receive an additional infusion of LR based on the formula: hourly rate, mL/hr = (1mL\*kg\*TBSA)/24 hr. this infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.

Timeline

• Start date: 2022-08-17
• Primary completion: 2024-06-29
• Completion: 2024-09-29
• First posted: 2020-12-23
• Last updated: 2025-01-29

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study