Burn InjuryPhase 3PREEVEnTNCT07212998
Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial
A Phase 3 study testing Plasma in people with Burn Injury and Thermal Burn, run by Jason Sperry at 1 site in United States.
Trial summary
The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 5-year (3-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burn Injury, Thermal Burn
- What is being tested?
- Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth
- Anticipated admission to burn ICU
Who cannot join
- Estimated rBaux score <55
- Not expected to survive >24 hours
- Wearing NO PREEVENT opt-out bracelet
- Age > 75 or < 18 years of age
- Concomitant traumatic injury with hemorrhagic shock
- Isolated chemical burn/injury
Show all 12Show fewer
- Isolated deep electrical burn/injury
- Known prisoner
- Known pregnancy
- Cardiac arrest with > 5 continuous minutes of CPR
- Concern for anoxic injury/ fixed pupils bilaterally
- Objection to study voiced by subject or family member at the scene or at the emergency department/burn center
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Jason Sperry, MD, 412-647-3065, sperryjl@upmc.edu
About this study
The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 5-year (3-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resuscitation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.
- Conditions
- Burn Injury, Thermal Burn
- Being tested
- Plasma, Standard care
- Keywords
- burn, plasma resuscitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaBiological
urgent release early plasma resuscitation following burn/thermal injury
Standard careBiological
Standard resuscitation as dictated by institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| Early Plasma Resuscitation | Experimental | 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)%. Receives: Biological: Plasma |
| Standard Care | Active comparator | Subjects will receive resuscitation following individual site standard burn resuscitation practice. Receives: Biological: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day Mortality or Persistent Organ Dysfunction
Composite outcome consisting of 28-day all-cause mortality, or 28-day Persistent Organ Dysfunction (POD) requiring support defined as 1) any intravenous vasopressor requirement, or 2) any renal replace therapy, or 3) any ventilator support/mechanical ventilation, or 4) continued need for intensive care unit (ICU) admission at 28 days.
Measured: 28 days
Secondary outcomes (12)
14-day mortality or Persistent Organ Dysfunction
Composite Outcome consisting of of 14-day all-cause mortality, or 14-day Persistent Organ Dysfunction requiring support (any intravenous vasopressor requirement, or any renal replace therapy, or any ventilator support, or continued need for intensive care unit (ICU) admission at 14 days)
Measured: 14 days
Arterial or venous thromboembolism in first 7 days
Pulmonary embolism, venous thrombosis, or arterial thrombosis that occurs during the primary admission hospital stay during the first 7 days from randomization. Radiographic confirmation via CT imaging, ultrasound, duplex, transthoracic or trans-esophageal echo, or ventilation/perfusion scanning will be required. If an embolic event is unable to be verified radiographically, presumed or clinical suspicion of an embolic event will also be documented.
Measured: 7 days
Acute respiratory distress syndrome (ARDS) in first 7 days
The Berlin definition for mild ARDS (PaO2/FIO2, ≤ 300 mmHg + timing, imaging and origin criteria) will be utilized as a threshold value to determine the incidence of ARDS
Measured: 7 days
Abdominal compartment syndrome
Intra-abdominal hypertension requiring paralysis, and/or diagnostic peritoneal lavage, and/or decompressive laparotomy
Measured: Enrollment through hospital discharge or 28 days
In-hospital mortality
Death prior to hospital discharge
Measured: Enrollment through hospital discharge or 28 days
24-hour and 48-hour resuscitation
All crystalloid, colloid (albumin) and plasma resuscitation, including the utilization of vitamin C
Measured: Enrollment through 24 hours and 48 hours
Acute kidney injury
At least one instance of a serum creatinine ≥ 1.5
Measured: Between 24 and 72 hours from the time of randomization
Nosocomial Infection
CDC criteria for the diagnosis of hospital-acquired pneumonia and blood stream infection will be utilized
Measured: 28 days
Ventilator-free days
Ventilator-free days will be determined by subtracting the number of ventilator days where mechanical ventilation was required utilizing an endotracheal tube or tracheostomy from 28 days. Patients undergoing operative interventions who remain on mechanical ventilation in the ICU will be considered to require ventilator support for that day.
Measured: 28 days
ICU- free days
ICU-free days will be determined by subtracting the number of days where ICU admission was required from 28 days.
Measured: 28 days
Allergic/transfusion reaction
Any transfusion complication during the initial 12 hours of enrollment will be documented. As the intervention is specific to the early phase of care setting and since transfusion complications are temporally related to the specific transfusion, transfusion-related complications will only be assessed during the initial 12 hours from randomization.
Measured: Initial 12 hours from randomization
Persistent Organ Dysfunction (POD) Days
POD days will be determined based on the number of calendar days during which the patient was determined to be in POD (≥1 on total daily score), starting at day of randomization and ending at day 28.
Measured: Starting at day of randomization and ending at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start31 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- permuted block design with variable block sizes of 4 and 6, stratified by site
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jason Sperry
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Jason Sperry, University of Pittsburgh
- Investigators
- Jason Sperry, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212998
- Sponsor's protocol ID
- STUDY25030138
- Other IDs
- HT9425-24-3-0002
- Acronym
- PREEVEnT
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial
- ClinicalTrials.gov ID
- NCT07212998
- Acronym / sponsor ID
- PREEVEnT / STUDY25030138
- Conditions
- Burn Injury, Thermal Burn
- Keywords
- burn, plasma resuscitation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Jason SperryUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 8 Oct 2025 (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 Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 5-year (3-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resuscitation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- permuted block design with variable block sizes of 4 and 6, stratified by site
| Arm | Type | Receives |
|---|---|---|
| Early Plasma Resuscitation | Experimental | Biological: PlasmaSubjects 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)%. |
| Standard Care | Active comparator | Biological: Standard careSubjects will receive resuscitation following individual site standard burn resuscitation practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth
- Anticipated admission to burn ICU
Key exclusion criteria (12 listed)
- Estimated rBaux score <55
- Not expected to survive >24 hours
- Wearing NO PREEVENT opt-out bracelet
- Age > 75 or < 18 years of age
- Concomitant traumatic injury with hemorrhagic shock
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 |
|---|---|---|
| Plasmaurgent release early plasma resuscitation following burn/thermal injury | Biological | Early Plasma Resuscitation |
| Standard careStandard resuscitation as dictated by institutional protocol | Biological | Standard Care |
Primary outcome
28-day Mortality or Persistent Organ Dysfunction
Time frame: 28 days
Composite outcome consisting of 28-day all-cause mortality, or 28-day Persistent Organ Dysfunction (POD) requiring support defined as 1) any intravenous vasopressor requirement, or 2) any renal replace therapy, or 3) any ventilator support/mechanical ventilation, or 4) continued need for intensive care unit (ICU) admission at 28 days.
12 secondary outcomes
14-day mortality or Persistent Organ Dysfunction
Time frame: 14 days
Arterial or venous thromboembolism in first 7 days
Time frame: 7 days
Acute respiratory distress syndrome (ARDS) in first 7 days
Time frame: 7 days
Abdominal compartment syndrome
Time frame: Enrollment through hospital discharge or 28 days
In-hospital mortality
Time frame: Enrollment through hospital discharge or 28 days
24-hour and 48-hour resuscitation
Time frame: Enrollment through 24 hours and 48 hours
Acute kidney injury
Time frame: Between 24 and 72 hours from the time of randomization
Nosocomial Infection
Time frame: 28 days
Ventilator-free days
Time frame: 28 days
ICU- free days
Time frame: 28 days
Allergic/transfusion reaction
Time frame: Initial 12 hours from randomization
Persistent Organ Dysfunction (POD) Days
Time frame: Starting at day of randomization and ending at day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
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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.
Jason Sperry, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Plasma in people with Burn Injury and Thermal Burn, run by Jason Sperry 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 2 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Sperry, MD (4128028270, sperryjl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day Mortality or Persistent Organ Dysfunction (time frame: 28 days). 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 1 Sep 2026.