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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study completion, an average of 1 year
Awards & highlights

PROPOLIS Trial Summary

This trial is testing whether using plasma instead of salt water to treat patients with major burns will reduce complications and improve survival.

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.Check my eligibility
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.See study design
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.

PROPOLIS Trial 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.

PROPOLIS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
Secondary outcome measures
Acute Respiratory Distress Syndrome
Cytokines
Hemodynamic instability
+15 more

PROPOLIS 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

Find a Location

Who is running the clinical trial?

Cerus CorporationIndustry Sponsor
18 Previous Clinical Trials
4,774 Total Patients Enrolled
Coalition for National Trauma ResearchLead Sponsor
1 Previous Clinical Trials
7,600 Total Patients Enrolled
Leopoldo Cancio, MDPrincipal InvestigatorU.S. Army Burn Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Pathogen-Reduced Plasma for use?

"Pathogen-Reduced Plasma has been approved by the relevant authorities, solidifying its rating of 3 on our team's 1 to 3 scale."

Answered by AI

Are there still vacancies available for participants in this trial?

"This investigation, which was published on July 1st 2022, is no longer recruiting patients. Per clinicaltrials.gov's records, the last update to this trial occurred on July 18th of this same year. Despite that fact, there are still 109 other medical investigations actively searching for participants at present time."

Answered by AI

Is the age-range for this trial limited to those over 55 years of age?

"This research is only open to adults aged between 18 and 65. However, there are supplemental studies for those younger than 18 (30 trials) and older than 65 (82)."

Answered by AI

Might I be a suitable candidate for this medical experiment?

"This medical research is aiming to recruit 94 participants aged 18-65 who have suffered a burn. Furthermore, in order to be eligible for inclusion, individuals must meet the following prerequisites: anticipated survival beyond 24 hours post-injury, IV fluids administered over at least one day from injury time, weight of 40kg or higher and admission into the respective burning centre within 8 hours of their incident."

Answered by AI

In what geographic regions is this clinical investigation accessible?

"8 medical centres have been enrolled to run this trial, including University of Washington School of Medicine in Seattle, University of Maryland School of Medicine in Baltimore and U.S Army Burn Center at Fort Sam Houston. Additionally, 5 more facilities are participating."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas Medical Branch Shriners Burns Hospitals for Children
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Plasma Resuscitation Without Lung Injury
2022. "Plasma Resuscitation Without Lung Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04681638.
~9 spots leftby Jun 2024
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