Fresh Frozen Plasma vs Albumin for Burns

(FFP Trial)

Overseen By Blaire Balstad, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Pregnancy, Renal failure, Coagulopathy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best fluid for resuscitation in burn patients by comparing fresh frozen plasma (FFP) and albumin. The researchers seek to identify which fluid reduces the amount needed and improves recovery from burn effects. The study focuses on enhancing care in situations where medical help might be delayed, such as military conflicts. Adults with burns covering more than 20% of their body, treated within eight hours of injury at a specific burn center, may be eligible to participate. As an unphased trial, this study allows participants to contribute to vital research that could improve burn care in critical situations.

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 this trial's treatments are likely to be safe?

Research has shown that using fresh frozen plasma (FFP) is generally safe for treating burns. One study found that patients who received FFP experienced lower rates of severe infections, lung problems, and kidney failure. Another study demonstrated that FFP improved urine output and maintained fluid balance without causing serious issues.

For albumin, some evidence suggests it can aid in recovery from burn shock, but the quality of this evidence varies. One study found that albumin did not reduce the risk of multiple organ failure in burn patients. Another study found no clear connection between albumin use and lower short-term death rates in burn patients.

Overall, both FFP and albumin have been used safely, but they have different effects. The safety of albumin might not be as clear as that of FFP. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fresh frozen plasma (FFP) for treating burns because it offers a different approach than standard options like crystalloids or traditional albumin solutions. FFP contains a range of clotting factors and proteins which may help better manage inflammation and improve healing in burn patients. Unlike typical treatments that mainly focus on fluid replacement, FFP might enhance recovery by directly supporting the body's natural healing processes. This unique potential to address both fluid loss and inflammation is what makes FFP stand out as a promising treatment for burns.

What evidence suggests that this trial's treatments could be effective for burn resuscitation?

This trial will compare Fresh Frozen Plasma (FFP) with Albumin for treating severe burns. Research has shown that FFP can increase urine output and help balance fluid levels without causing major problems. Meanwhile, Albumin improves recovery during burn shock and might reduce the need for extra fluids, although the evidence supporting Albumin remains somewhat limited in scope and quality. Both treatments are considered safe, but each offers unique benefits for managing burn injuries. More research is needed to directly compare their effectiveness in treating burns. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 2-18 with severe burns covering more than 20% of their body, seen at UCH Burn Center within 8 hours of injury. It excludes those who can't receive blood products, have severe coagulation or liver issues, are prisoners, pregnant, or have certain types of injuries or kidney disease.

Inclusion Criteria

I am a child (2-18 years) with burns covering more than 20% of my body, seen within 8 hours of the injury.

Exclusion Criteria

You have severe injuries that are life-threatening.

I have moderate to severe liver cirrhosis.

Coagulopathy (admission INR >2.5)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Fresh Frozen Plasma (FFP) or Albumin for burn resuscitation

24 hours

In-hospital treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring fluid volume and complications

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Fresh Frozen Plasma

Trial Overview

The study compares the use of fresh frozen plasma (FFP) versus albumin in acute burn resuscitation to see which is better for managing fluid needs and correcting endothelial damage caused by burns. The goal is to improve care in prolonged field scenarios.

How Is the Trial Designed?

Group I: Fresh Frozen Plasma Active Control 1 Intervention

At 6-8 hours, Initiate FFP infusion

Group II: Albumin Active Control 1 Intervention

At 7 hours, Initiate 5% Albumin infusion

Fresh Frozen Plasma is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Fresh Frozen Plasma for:

• Acute burn resuscitation
• Coagulopathy correction
• Volume expansion in shock

Approved in European Union as Fresh Frozen Plasma for:

• Acute burn resuscitation
• Coagulopathy correction
• Volume expansion in shock

Approved in Canada as Fresh Frozen Plasma for:

• Acute burn resuscitation
• Coagulopathy correction
• Volume expansion in shock

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Colloids, such as fresh frozen plasma and albumin, are effective in improving fluid balance and reducing swelling in patients with major burns, as they enhance intravascular volume and osmotic pressure.

While fresh frozen plasma is effective for burn resuscitation, it carries risks like viral transmission and lung injury; albumin is a safer and more cost-effective alternative that also reduces the need for additional fluids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colloids in Acute Burn Resuscitation. Cartotto, R., Greenhalgh, D.[2017]

Solvent/detergent-treated plasma (SDP) and fresh-frozen plasma (FFP) have similar levels of most coagulation factors, but FFP contains significantly higher concentrations of factors V, von Willebrand factor, and ADAMTS-13, which are important for blood clotting.

Cytokine levels, including TNF-α, IL-8, and IL-10, were also higher in FFP compared to SDP, indicating that FFP may have a broader range of immune response factors, although the clinical significance of these differences needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative concentrations of haemostatic factors and cytokines in solvent/detergent-treated and fresh-frozen plasma. Theusinger, OM., Baulig, W., Seifert, B., et al.[2018]

Fresh frozen plasma (FFP) is a safe and effective volume expander that can reduce the overall fluid requirements during acute burn resuscitation, potentially improving patient outcomes.

Newer forms of plasma, such as solvent-detergent-treated plasma and lyophilized plasma, may offer even greater safety and efficacy, warranting further investigation as adjuncts in burn treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review on the Use of Plasma During Acute Burn Resuscitation. Cartotto, R., Callum, J.[2021]

In a study of 586 adult burn patients, using a higher ratio of frozen plasma to plasma substitutes (≥2:1) within 48 hours of admission significantly improved 30-day survival rates and reduced in-hospital mortality compared to lower ratios.

The study found that a greater burn area was an independent risk factor for 30-day mortality, while a higher infusion ratio of frozen plasma was identified as a protective factor, suggesting that optimizing plasma use can enhance patient outcomes in severe burn cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the infusion ration between frozen plasma and plasma substitutes on the prognosis of adult patients with major burn in shock stage. Xiao, K., Zhao, F., Wan, J., et al.[2021]

Fresh frozen plasma (FFP) is effective for actively bleeding patients with multiple coagulation factor deficiencies and for preventing dilutional coagulopathy in major trauma cases, but current dosing recommendations may be inadequate.

Transfusing FFP to non-bleeding patients with mild coagulation issues is not supported by evidence and poses unnecessary risks, including serious complications like transfusion-related acute lung injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative coagulation management--fresh frozen plasma. Kor, DJ., Stubbs, JR., Gajic, O.[2019]

Early administration of fresh frozen plasma (FFP) in a large animal model of traumatic brain injury (TBI) and hemorrhagic shock (HS) significantly reduced neurologic impairment and accelerated recovery over a 30-day period, compared to normal saline treatment.

FFP-treated animals showed a trend towards smaller brain lesions and were able to participate in cognitive testing 8 days earlier than those treated with saline, indicating improved cognitive function preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early resuscitation with fresh frozen plasma for traumatic brain injury combined with hemorrhagic shock improves neurologic recovery. Halaweish, I., Bambakidis, T., He, W., et al.[2022]

A systematic review of 10 studies found that organizational interventions significantly reduced the risk of inappropriate fresh-frozen plasma (FFP) transfusions, with a risk ratio of 2.02 before interventions compared to after.

Implementing these interventions is crucial for improving clinician practices and ensuring safer transfusion procedures, thereby promoting better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriateness of fresh-frozen plasma usage in hospital settings: a meta-analysis of the impact of organizational interventions. Damiani, G., Pinnarelli, L., Sommella, L., et al.[2019]

In a study of 209 patients with severe burns covering more than 30% of their body, those treated with fresh frozen plasma (FFP) had a significantly lower mortality rate (33.8%) compared to those treated with albumin (78.9%).

The findings suggest that the type of colloid treatment used in burn patients can greatly impact survival rates, highlighting the potential benefits of using FFP over albumin in managing severe burn injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Albumin and Fresh Frozen Plasma as Colloid Therapy in Patients With Major Burns. Vural, S., Yasti, CA., Dolapçı, M.[2023]

In a study involving 24 splenectomized dogs, resuscitation from hemorrhagic shock using fresh-frozen plasma (FFP) alongside red blood cells (PRBCs) and electrolyte solution resulted in improved cardiac output and left ventricular stroke work compared to controls.

FFP resuscitation did not negatively affect the balance of pulmonary capillary wedge pressure and left ventricular stroke work ratio, suggesting it is a safe alternative volume expander that maintains protein levels in the bloodstream.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fresh-frozen plasma resuscitation on cardiopulmonary function and serum protein flux. Lucas, CE., Martin, DJ., Ledgerwood, AM., et al.[2019]

A systematic review of 15 trials involving 755 participants found no significant difference in mortality rates for patients undergoing cardiovascular surgery who received fresh frozen plasma (FFP) compared to those who did not, indicating that FFP may not be effective as a prophylactic treatment in this context.

FFP transfusion was associated with a higher likelihood of requiring red cell transfusions, suggesting that while it may improve prothrombin time, it does not translate into clinical benefits for reducing blood loss or mortality in elective cardiac surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fresh frozen plasma for cardiovascular surgery. Desborough, M., Sandu, R., Brunskill, SJ., et al.[2022]

In a study of 33 critically ill patients, transfusion of fresh frozen plasma (FFP) significantly reduced levels of the inflammatory cytokine TNF-α, indicating a potential anti-inflammatory effect.

FFP transfusion also improved endothelial condition by decreasing syndecan-1 and factor VIII levels while increasing ADAMTS13, suggesting a stabilization of the endothelial lining, which is important for vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transfusion of fresh frozen plasma on parameters of endothelial condition and inflammatory status in non-bleeding critically ill patients: a prospective substudy of a randomized trial. Straat, M., Müller, MC., Meijers, JC., et al.[2022]

A study of 392 children with burns showed that implementing blood conserving techniques during surgery led to significant reductions in the use of blood products, including a 100% reduction in fresh frozen plasma (FFP) for small burns and up to 89% reduction in packed red blood cells (pRBC) for small burns.

Despite these reductions in blood product use, patient survival rates remained high, with 97% in the first group and 98% in the second group, indicating that these blood conservation strategies do not compromise patient safety or clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in blood conservation in burn care. Sheridan, RL., Szyfelbein, SK.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4851230/

Albumin in Burn Shock Resuscitation: A Meta-Analysis of ...

This meta-analysis suggests that albumin can improve outcomes of burn shock resuscitation. However, the scope and quality of current evidence are limited.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0305417924002304

Effect of fluid resuscitation with albumin on mortality in ...

This study aimed to examine whether albumin administration is associated with reduced 28-day mortality in patients with severe burns, using a nationwide ...

3.

journals.lww.com

journals.lww.com/jcma/fulltext/2020/02000/albumin_supplementation_may_have_limited_effects.17.aspx

Albumin supplementation may have limited effects on...

The purpose of this study was to determine whether human albumin solutions can benefit major burn patients with persistent hypoalbuminemia.

4.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT04928859

Study on Efficacy and Safety of Human Albumin in Burn ...

The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications. Official Title. Study ...

5.

medintensiva.org

medintensiva.org/es-download-pdf-S0210569116000024

First resuscitation of critical burn patients

suggests that albumin can improve outcomes of burn shock resuscitation.12,13. It has also shown efficacy in reducing the need for fluid intake with other ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16398734/

Five percent albumin for adult burn shock resuscitation

Conclusion: Treatment with 5 percent albumin from Day 0 to Day 14 does not decrease the burden of MODS in adult burn patients.