Plasma Resuscitation for Thermal Burns

(PREEVEnT Trial)

Overseen By Jason Sperry, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Jason Sperry

Disqualifiers: Age, Pregnancy, Traumatic injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether starting plasma resuscitation (a type of fluid replacement using plasma) quickly after a severe burn is more effective than usual methods. It targets individuals with large second or third-degree burns covering at least 20% of their body. The goal is to determine if this approach reduces complications and deaths. Individuals with severe burns requiring treatment in a burn ICU might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that plasma resuscitation is likely to be safe for humans?

Studies have shown that using plasma to treat burn patients is generally safe. Research indicates that plasma does not cause harmful changes in blood clotting or bleeding in these patients, meaning plasma treatment is usually well-tolerated.

Replacing lost fluids is a standard treatment for people with serious burns to prevent complications. Plasma resuscitation, a type of fluid replacement, uses plasma, a component of blood. While more research is always helpful, current evidence supports the safety of plasma in treating burns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care for burn resuscitation, which typically involves fluids like saline or lactated Ringer's solution, plasma resuscitation offers a unique approach. Researchers are excited about this treatment because it uses plasma to potentially improve fluid management and stabilize patients more effectively after severe burns. Plasma contains proteins and clotting factors that could help reduce complications and improve healing, showing promise for better outcomes than traditional fluid resuscitation methods.

What evidence suggests that plasma resuscitation is effective for thermal burns?

Research has shown that starting plasma treatment early is crucial for patients with severe burns. In this trial, participants in the "Early Plasma Resuscitation" arm will receive plasma resuscitation initiated in the emergency department over approximately four hours. Studies indicate that timely fluid administration can reduce complications and improve recovery, such as lowering the risk of organ failure and death. This is particularly important for burns covering more than 20% of an adult's body. Plasma treatment restores blood volume and improves circulation after a burn, aiding the body's healing process. Although more research is needed, early findings suggest that plasma treatments do not increase the risk of blood clots, making them a safe option for treating severe burns. ^{1 3 4 5 6}

Who Is on the Research Team?

Jason Sperry, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

The PREEVEnT trial is for adults who have suffered large second or third degree burns covering at least 20% of their body and require fluid replacement therapy. The study seeks participants immediately upon arrival to an emergency department or burn unit.

Inclusion Criteria

Anticipated admission to burn ICU

I have burns covering 20% or more of my body.

Exclusion Criteria

Concomitant traumatic injury with hemorrhagic shock

Isolated deep electrical burn/injury

Known prisoner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Plasma Resuscitation

Subjects receive early plasma resuscitation initiated in the emergency department/burn resuscitation area over an approximate 4-hour period from the time of randomization

4 hours

Standard Care

Subjects receive resuscitation following individual site standard burn resuscitation practice

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Plasma Resuscitation

Trial Overview This trial tests if starting plasma resuscitation right away for patients with extensive thermal burns leads to better outcomes than the usual care. It's a phase-3 study, meaning it's in a later stage of testing, involving multiple burn centers over six years.

How Is the Trial Designed?

Group I: Early Plasma Resuscitation Experimental Treatment 1 Intervention

Subjects will receive early plasma resuscitation initiated in the emergency department/burn resuscitation area over an approximate 4-hour period from the time of randomization, stratified by Total Body Surface Area (TBSA)%.

Group II: Standard Care Active Control 1 Intervention

Subjects will receive resuscitation following individual site standard burn resuscitation practice.

Who Is Running the Clinical Trial?

Jason Sperry

Lead Sponsor

Trials

9

Recruited

6,900+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK534227/

Burn Fluid Resuscitation - StatPearls - NCBI Bookshelf Fluid resuscitation is required for burns exceeding 20% total body surface area in adults and 10% to 15% in children.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0300957200001751

Early fluid resuscitation improves outcomes in severely ... Background: Recent evidence suggests that timely fluid resuscitation can significantly reduce multiorgan failure and mortality in thermally injured children ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07212998

Study Details | NCT07212998 | Plasma Resuscitation Early ... Inclusion Criteria: Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth; Anticipated admission to burn ICU.

4. emedicine.medscape.com emedicine.medscape.com/article/1277360-overview

Burn Resuscitation and Early Management Burn resuscitation refers to the replacement of fluids in burn patients to combat the hypovolemia and hypoperfusion that can result from the body's systemic ...

5. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(24)00557-2/fulltext

Plasma Inclusive Resuscitation Is Not Associated With ... Data suggest that PIR was not associated with prothrombotic or lytic changes in burn patients relative to baseline. Further research is needed ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480424005572

Plasma Inclusive Resuscitation Is Not Associated With ... Data suggest that PIR was not associated with prothrombotic or lytic changes in burn patients relative to baseline.