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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-24-3-0002 | Other Grant/Funding Number | U.S. Department of Defense (DoD) |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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)%. |
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| Standard Care | Active Comparator | Subjects will receive resuscitation following individual site standard burn resuscitation practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma | Biological | urgent release early plasma resuscitation following burn/thermal injury |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Sperry, MD | Contact | 4128028270 | sperryjl@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Sperry, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator
Data will become available after publication of the primary manuscript
Requests for data will be submitted in writing and reviewed by the Principal Investigator.
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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permuted block design with variable block sizes of 4 and 6, stratified by site
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| Standard care | Biological | Standard resuscitation as dictated by institutional protocol |
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| 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. | 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 | 7 days |
| Abdominal compartment syndrome | Intra-abdominal hypertension requiring paralysis, and/or diagnostic peritoneal lavage, and/or decompressive laparotomy | Enrollment through hospital discharge or 28 days |
| In-hospital mortality | Death prior to hospital discharge | 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 | Enrollment through 24 hours and 48 hours |
| Acute kidney injury | At least one instance of a serum creatinine ≥ 1.5 | 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 | 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. | 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. | 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. | 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. | Starting at day of randomization and ending at day 28 |