Plasma Resuscitation Without Lung Injury (PROPOLIS)

Coalition for National Trauma Research

Status and phase: Terminated; Phase 4

Conditions: Burns

Treatments: Drug: Crystalloid Solutions; Drug: Pathogen-Reduced Plasma

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04681638

CDMRP-DM190167 (Other Grant/Funding Number)

CNTR-2020-001

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Weight > 40 kg
• Initial assessment of thermal injury size ≥ 20% TBSA
• Admitted to the burn center and enroll able within 8 hours of injury
• Expected to receive intravenous resuscitation fluids for at least 24 hours after injury
• Expected to live > 24 hours after injury

Exclusion criteria

• Chemical injury
• Deep electric injury
• Associated non-thermal injuries with estimated Injury Severity Score > 25
• Inability to obtain informed consent
• Decision not to treat due to injury severity or other factors
• Patient age > 65 years or < 18 years
• Presence of anoxic brain injury that is not expected to result in complete recover
• Patent already receiving plasma infusion, or judged to be likely to require plasma infusion
• Patent already receiving "rescue procedures" (albumin infusion, CRRT, TPE, or high-dose ascorbic acid)
• Existence of pre-morbid conditions: Congestive heart failure (NYHA Class IV); End-stage kidney disease (dialysis patient); Cirrhosis of the liver; Oxygen-dependent chronic obstructive pulmonary disease; Malignancy currently under treatment; Previous bilateral lower extremity amputations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Plasma

Experimental group

Description:

Pathogen-Reduced Plasma resuscitation

Treatment:

Drug: Pathogen-Reduced Plasma

Crystalloid

Active Comparator group

Description:

Standardized crystalloid resuscitation

Treatment:

Drug: Crystalloid Solutions