Plasma Resuscitation Without Lung Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2024-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is an open-label, phase IV, multicenter, randomized controlled prospective clinical trial in patients with burns. The study model is parallel (between-patient). The intervention to be tested is Pathogen-Reduced Plasma for burn shock resuscitation vs. standard-of-care resuscitation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plasma

Pathogen-Reduced Plasma resuscitation

Group Type EXPERIMENTAL

Pathogen-Reduced Plasma

Intervention Type DRUG

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.

Crystalloid

Standardized crystalloid resuscitation

Group Type ACTIVE_COMPARATOR

Crystalloid Solutions

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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PRP LR

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No