What side effects are associated with this type of intervention?

Common treatments for burns, such as fluid resuscitation and plasma therapy, can have several side effects. Fluid resuscitation often involves the administration of large volumes of crystalloids or colloids, which can lead to complications like fluid overload, pulmonary edema, and acute kidney injury. Plasma therapy, which aims to reduce fluid volume and inflammation, may decrease the risk of lung and kidney injury but can still cause issues such as allergic reactions, transfusion-related acute lung injury (TRALI), and infections. Additionally, the use of plasma requires careful monitoring to avoid complications related to fluid balance and immune responses.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for treatments of burns that are similar to the plasma treatment being studied. However, it does highlight the potential benefits of using plasma to reduce fluid volume and inflammation, which may decrease lung and kidney injury in burn patients. This suggests that while plasma treatment is under investigation, there may not yet be FDA-approved treatments specifically targeting these outcomes in burn care.

What other types of research exist?

Promising novel alternatives to plasma for burn patients include nebulized heparin, which may reduce lung injury by addressing pulmonary coagulopathy, and nicotinic acid, which has shown potential in reducing plasma extravasation and stabilizing cardiac output post-burn.

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Plasma

Plasma Resuscitation for Burns (PROPOLIS Trial)

Phase 4

Recruiting

Led By Leopoldo Cancio, MD

Research Sponsored by Coalition for National Trauma Research

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Expected to receive intravenous resuscitation fluids for at least 24 hours after injury

Weight > 40 kg

Must not have

Patient already receiving "rescue procedures" (albumin infusion, CRRT, TPE, or high-dose ascorbic acid)

Chemical injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study completion, an average of 1 year

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial uses specially treated plasma to help patients with major burns. The goal is to reduce the amount of fluid needed, which should prevent organ damage and improve recovery. This approach targets burn patients who often suffer from complications due to excessive fluid resuscitation. Plasma has been considered a better fluid for burn patients due to its ability to restore blood volume and treat burn-related complications.

Who is the study for?

This trial is for adults over 18 and under 65 years old with severe burns covering at least 20% of their body, weighing more than 40 kg, expected to live more than a day after injury, and can start treatment within 8 hours. It's not for those with electric or chemical injuries, other serious injuries, certain chronic diseases like heart failure or COPD, cancer under treatment, or previous major amputations.

What is being tested?

The study tests if pathogen-reduced plasma can reduce fluid needed in the first day after a burn to prevent lung damage compared to standard salt water solutions. The goal is to lessen lung injury risk and improve recovery by decreasing inflammation and hospital stay duration.

What are the potential side effects?

While specific side effects are not listed here, generally plasma transfusions may cause allergic reactions, breathing difficulties, infections from blood-borne pathogens despite pathogen reduction treatments; crystalloid solutions might lead to electrolyte imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will need IV fluids for at least a day after my injury.

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I weigh more than 40 kg.

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I am older than 18 years.

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I was admitted to the burn center within 8 hours of getting burned.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing treatments like albumin infusion or CRRT.

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I have suffered a chemical injury.

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I am either older than 65 or younger than 18.

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I am currently receiving or likely to need plasma infusions.

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I do not have severe heart failure, end-stage kidney disease, advanced liver cirrhosis, need for constant oxygen due to lung disease, cancer under treatment, or both legs amputated.

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I have a brain injury from lack of oxygen and am not expected to fully recover.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.

Secondary study objectives

Acute Respiratory Distress Syndrome

Cytokines

Hemodynamic instability

+15 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: PlasmaExperimental Treatment1 Intervention

Pathogen-Reduced Plasma resuscitation

Group II: CrystalloidActive Control1 Intervention

Standardized crystalloid resuscitation

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for burns include fluid resuscitation, wound care, pain management, and infection prevention. Plasma resuscitation, a specific type of fluid therapy, involves using plasma instead of crystalloids to restore blood volume. Plasma contains proteins and clotting factors that help maintain oncotic pressure, reducing the total volume of fluids needed. This is crucial for burn patients as it minimizes the risk of fluid overload, which can lead to lung and kidney injury. Additionally, plasma has anti-inflammatory properties that can decrease systemic inflammation, further protecting vital organs and improving overall outcomes.

[Effect of mannitol on serum tumor necrosis factor-α and interleukin-6 levels and the mechanism of its organ-protective effect in rabbits early after severe burn injury].