BurnsPhase 4PROPOLISNCT04681638
Plasma Resuscitation Without Lung Injury
A Phase 4 study testing Pathogen-Reduced Plasma and Crystalloid Solutions in people with Burns, run by Coalition for National Trauma Research at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Pathogen-Reduced Plasma and Crystalloid Solutions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Aug 2022to 29 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Maryland School of Medicine
Baltimore, Maryland, 21201
University of Alabama at Birmingham Burn Center
Birmingham, Alabama, 35294
U.S. Army Burn Center
Fort Sam Houston, Texas, 78234-6315
University of Texas Medical Branch
Galveston, Texas, 77555
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Washington School of Medicine
Seattle, Washington, 98104-2499
About this study
Official title: Plasma Resuscitation withOut Lung Injury
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.
- Conditions
- Burns
- Being tested
- Pathogen-Reduced Plasma, Crystalloid Solutions
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pathogen-Reduced PlasmaDrug
Also called PRP
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 SolutionsDrug
Also called LR
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.
| Study group | Role | What they receive |
|---|---|---|
| Plasma | Experimental | Pathogen-Reduced Plasma resuscitation Receives: Drug: Pathogen-Reduced Plasma |
| Crystalloid | Active comparator | Standardized crystalloid resuscitation Receives: Drug: Crystalloid Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg
Measured: 24 hours
Secondary outcomes (18)
Total resuscitation volume in ml/kg
The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg
Measured: 48 hours
Total 24 hour resuscitation volume in ml/kg/TBSA
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg/TBSA
Measured: 24 hours
Total 48 hour resuscitation volume in ml/kg/TBSA
The total volume of all resuscitation fluids delivered between hours 0-48 postburn, in ml/kg/TBSA
Measured: 48 hours
Hemodynamic instability
Severity and duration of hemodynamic instability during hours 0-48 postburn (norepinephrine equivalents)
Measured: 48 hours
Metabolic acidosis
Severity and duration of metabolic acidosis (arterial lactate levels)
Measured: 48 hours
Incidence of "rescue" (a)
Initiation of extracorporeal therapy (continuous renal replacement therapy or therapeutic plasma exchange
Measured: 48 hours
Incidence of "rescue" (b)
Infusion of high-dose ascorbic acid (66 mg/kg/hr)
Measured: 48 hours
Incidence of "rescue" (c)
Initiation of a continuous infusion of albumin
Measured: 24 hours
Acute Respiratory Distress Syndrome
Incidence of Acute Respiratory Distress Syndrome using Berlin Criteria
Measured: 7 days
Mechanical ventilation
Ventilator free days
Measured: 28 days
Intensive Care Unit days
Intensive Care Unit free days
Measured: 28 days
Multi-Organ Failure Assessment
Sequential Organ Failure Assessment scores. Minimum score 1, maximum score 4. The higher the score the worse the outcome.
Measured: 7 days
Transfusion-Related Acute Lung Injury
Incidence of Transfusion-Related Acute Lung Injury, Type I or II.
Measured: 72 hours
Thromboembolic events
Incidence of venous thrombosis-embolic events (deep vein thrombosis or pulmonary embolism)
Measured: 7 days
Mortality
In hospital mortality
Measured: throughout study completion, an average of 1 year
Patient reported outcomes
Patient reported outcomes using the Patient Reported Outcomes Measurement Information System, Global 10. This scale10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. Higher scores equal a healthier patient.
Measured: 6 months
Syndecan-1 levels
Syndecan-1 level in ng/dl
Measured: 48 hours
Cytokines
Cytokines
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start17 Aug 2022
- Primary completion29 Jun 2024
- Study completion29 Sep 2024
Why it stopped: Enrollment targets were unable to be reached due to difficulty in locating and contacting the Legally Authorized Representative (LAR). Even with prolonged enrollment timeframe, the study was unable to obtain consent from the LAR.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coalition for National Trauma Research
- Sponsor type
- University, hospital or other
- Collaborators
- Cerus Corporation
- Responsible party
- Sponsor
- Investigators
- Leopoldo Cancio, MD, Principal investigator, U.S. Army Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681638
- Sponsor's protocol ID
- CNTR-2020-001
- Other IDs
- CDMRP-DM190167
- Acronym
- PROPOLIS
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2020
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Resuscitation withOut Lung Injury
- ClinicalTrials.gov ID
- NCT04681638
- Acronym / sponsor ID
- PROPOLIS / CNTR-2020-001
- Conditions
- Burns
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment targets were unable to be reached due to difficulty in locating and contacting the Legally Authorized Representative (LAR). Even with prolonged enrollment timeframe, the study was unable to obtain consent from the LAR.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Coalition for National Trauma ResearchUniversity, hospital or other
- Collaborators
- Cerus Corporation
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Plasma | Experimental | Drug: Pathogen-Reduced PlasmaPathogen-Reduced Plasma resuscitation |
| Crystalloid | Active comparator | Drug: Crystalloid SolutionsStandardized crystalloid resuscitation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pathogen-Reduced PlasmaAlso: PRPThe 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. | Drug | Plasma |
| Crystalloid SolutionsAlso: LRThe 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. | Drug | Crystalloid |
Primary outcome
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg.
Time frame: 24 hours
The total volume of all resuscitation fluids delivered between hours 0-24 postburn, in ml/kg
18 secondary outcomes
Total resuscitation volume in ml/kg
Time frame: 48 hours
Total 24 hour resuscitation volume in ml/kg/TBSA
Time frame: 24 hours
Total 48 hour resuscitation volume in ml/kg/TBSA
Time frame: 48 hours
Hemodynamic instability
Time frame: 48 hours
Metabolic acidosis
Time frame: 48 hours
Incidence of "rescue" (a)
Time frame: 48 hours
Incidence of "rescue" (b)
Time frame: 48 hours
Incidence of "rescue" (c)
Time frame: 24 hours
Acute Respiratory Distress Syndrome
Time frame: 7 days
Mechanical ventilation
Time frame: 28 days
Intensive Care Unit days
Time frame: 28 days
Multi-Organ Failure Assessment
Time frame: 7 days
Transfusion-Related Acute Lung Injury
Time frame: 72 hours
Thromboembolic events
Time frame: 7 days
Mortality
Time frame: throughout study completion, an average of 1 year
Patient reported outcomes
Time frame: 6 months
Syndecan-1 levels
Time frame: 48 hours
Cytokines
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: Enrollment targets were unable to be reached due to difficulty in locating and contacting the Legally Authorized Representative (LAR). Even with prolonged enrollment timeframe, the study was unable to obtain consent from the LAR.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leopoldo Cancio, MD principal investigator
U.S. Army Burn Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pathogen-Reduced Plasma and Crystalloid Solutions in people with Burns, run by Coalition for National Trauma Research at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment targets were unable to be reached due to difficulty in locating and contacting the Legally Authorized Representative (LAR). Even with prolonged enrollment timeframe, the study was unable to obtain consent from the LAR.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total volume of all resuscitation fluids delivered between hours 0-24 postern, in ml/kg. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.