BurnsFFPNCT05069922
Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
A study testing Fresh Frozen Plasma in people with Burns, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Burns
- What is being tested?
- Fresh Frozen Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2022to 31 Aug 2025
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult thermal injury patients aged 2:18 years old with burns ->20% TBSA seen at UCH Burn Center within 8 hours of burn injury
Who cannot join
- Pregnant patients, prisoners, Jehovah's Witness/inability to receive human blood product/component therapy, electrical injury, chemical injury, friction/shear injury, anticipated death within 48 hours of admission, delayed intervention (>8 hours post burn), history of renal failure requiring dialysis, Stage IV or V chronic kidney disease, coagulopathy (admission INR >2.5), cirrhosis (Childs B,C), concomitant life threatening traumatic injuries, receiving blood product transfusion for another reason, inability to obtain consent from patient or legally authorized representative.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
The investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention, such as prevention of over resuscitation. Future military conflicts anticipate more extensive burn and blast injuries, and delayed evacuation. Therefore, the direct comparison of colloids used in burn resuscitation is critical to advancing battlefield medicine. Specifically, this work will provide the foundation for the use of freeze-dried plasma (FDP) in burn care by medical responders in PFC and en route care scenarios. The investigators hypothesize that FFP administration, and later FDP, in burn resuscitation is as safe as albumin, and more efficacious, in both reducing the total volume of fluid required in acute burn resuscitation and correcting burn endotheliopathy.
Read the detailed description
Specific Aim 1: The investigators will evaluate the total fluids administered in FFP (intervention) and albumin (control) groups. The investigators propose that the FFP group will require less total fluids administered.
Specific Aim 2:The investigators will determine overall complication rates (pulmonary complications, ARDS, ACS, over-resuscitation) in the FFP (intervention) and albumin (control) administration groups. The investigators propose FFP administration will reduce the frequency of these complications.
Specific Aim 3: The investigators will characterize the effects of FFP and albumin administration on endothelial dysfunction in major burns. We will measure glycocalyx degradation products (e.g. syndecan-1, glycosaminoglycans) in the serum. The investigators project FFP will mitigate GDP better than albumin.
- Conditions
- Burns
- Being tested
- Fresh Frozen Plasma
- Keywords
- Burn resuscitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Frozen PlasmaOther
Also called Albumin
Fresh Frozen Plasma
| Study group | Role | What they receive |
|---|---|---|
| Fresh Frozen Plasma | Active comparator | At 6-8 hours, Initiate FFP infusion Receives: Other: Fresh Frozen Plasma |
| Albumin | Active comparator | At 7 hours, Initiate 5% Albumin infusion Receives: Other: Fresh Frozen Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned.
Total volume
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start17 Feb 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069922
- Sponsor's protocol ID
- 21-3710
- Other IDs
- CDMRP-MB200032
- Acronym
- FFP
- Status last verified
- Nov 2025
- First submitted
- 27 Sep 2021
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be compiled and shared with Department of Defense
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation
- ClinicalTrials.gov ID
- NCT05069922
- Acronym / sponsor ID
- FFP / 21-3710
- Conditions
- Burns
- Keywords
- Burn resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 Oct 2021 (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 investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention, such as prevention of over resuscitation. Future military conflicts anticipate more extensive burn and blast injuries, and delayed evacuation. Therefore, the direct comparison of colloids used in burn resuscitation is critical to advancing battlefield medicine. Specifically, this work will provide the foundation for the use of freeze-dried plasma (FDP) in burn care by medical responders in PFC and en route care scenarios. The investigators hypothesize that FFP administration, and later FDP, in burn resuscitation is as safe as albumin, and more efficacious, in both reducing the total volume of fluid required in acute burn resuscitation and correcting burn endotheliopathy.
Detailed description
Specific Aim 1: The investigators will evaluate the total fluids administered in FFP (intervention) and albumin (control) groups. The investigators propose that the FFP group will require less total fluids administered.
Specific Aim 2:The investigators will determine overall complication rates (pulmonary complications, ARDS, ACS, over-resuscitation) in the FFP (intervention) and albumin (control) administration groups. The investigators propose FFP administration will reduce the frequency of these complications.
Specific Aim 3: The investigators will characterize the effects of FFP and albumin administration on endothelial dysfunction in major burns. We will measure glycocalyx degradation products (e.g. syndecan-1, glycosaminoglycans) in the serum. The investigators project FFP will mitigate GDP better than albumin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Frozen Plasma | Active comparator | Other: Fresh Frozen PlasmaAt 6-8 hours, Initiate FFP infusion |
| Albumin | Active comparator | Other: Fresh Frozen PlasmaAt 7 hours, Initiate 5% Albumin infusion |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult thermal injury patients aged 2:18 years old with burns ->20% TBSA seen at UCH Burn Center within 8 hours of burn injury
Key exclusion criteria (1 listed)
- Pregnant patients, prisoners, Jehovah's Witness/inability to receive human blood product/component therapy, electrical injury, chemical injury, friction/shear injury, anticipated death within 48 hours of admission, delayed intervention (>8 hours post burn), history of renal failure requiring dialysis, Stage IV or V chronic kidney disease, coagulopathy (admission INR >2.5), cirrhosis (Childs B,C), concomitant life threatening traumatic injuries, receiving blood product transfusion for another reason, inability to obtain consent from patient or legally authorized representative.
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 |
|---|---|---|
| Fresh Frozen PlasmaAlso: AlbuminFresh Frozen Plasma | Other | Albumin, Fresh Frozen Plasma |
Primary outcome
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned.
Time frame: 3 years
Total volume
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No. Data will be compiled and shared with Department of Defense
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Frozen Plasma in people with Burns, run by University of Colorado, Denver at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total volume of fluid administered in 24 hours in each group (FFP or albumin), measured as mL/kg/%TBSA burned. (time frame: 3 years). 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 13 Nov 2025.