Burn Injury, Thermal Burn
Conditions
Keywords
burn, plasma resuscitation
Brief 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 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.
Interventions
BIOLOGICALPlasma
urgent release early plasma resuscitation following burn/thermal injury
BIOLOGICALStandard care
Standard resuscitation as dictated by institutional protocol
Sponsors
Jason Sperry
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
permuted block design with variable block sizes of 4 and 6, stratified by site
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth * Anticipated admission to burn ICU
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day Mortality or Persistent Organ Dysfunction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 14-day mortality or Persistent Organ Dysfunction | 14 days | 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) |
| Arterial or venous thromboembolism in first 7 days | 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. |
| Acute respiratory distress syndrome (ARDS) in first 7 days | 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 |
| Abdominal compartment syndrome | Enrollment through hospital discharge or 28 days | Intra-abdominal hypertension requiring paralysis, and/or diagnostic peritoneal lavage, and/or decompressive laparotomy |
| In-hospital mortality | Enrollment through hospital discharge or 28 days | Death prior to hospital discharge |
| 24-hour and 48-hour resuscitation | Enrollment through 24 hours and 48 hours | All crystalloid, colloid (albumin) and plasma resuscitation, including the utilization of vitamin C |
| Acute kidney injury | Between 24 and 72 hours from the time of randomization | At least one instance of a serum creatinine ≥ 1.5 |
| Nosocomial Infection | 28 days | CDC criteria for the diagnosis of hospital-acquired pneumonia and blood stream infection will be utilized |
| Ventilator-free days | 28 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. |
| ICU- free days | 28 days | ICU-free days will be determined by subtracting the number of days where ICU admission was required from 28 days. |
| Allergic/transfusion reaction | Initial 12 hours from randomization | 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. |
| Persistent Organ Dysfunction (POD) Days | Starting at day of randomization and ending at day 28 | 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. |
Countries
United States
Contacts
CONTACTJason Sperry, MD
PRINCIPAL_INVESTIGATORJason Sperry, MD
University of Pittsburgh
Outcome results
None listed