Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial

Browse trials for

• Burns 905

Keywords

• burn
• plasma resuscitation

Burns

905 studies on the registry are indexed under Burns; 164 are open to participants now.

This study's planned enrollment of 750 is above the median of 40 across 663 interventional studies indexed under Burns.

Lead sponsor

Jason Sperry is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Study arms

• Experimental
  Early Plasma Resuscitation

  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)%.

  Biological: Plasma

• Active comparator
  Standard Care

  Subjects will receive resuscitation following individual site standard burn resuscitation practice.

  Biological: Standard care

Interventions

• BiologicalPlasma

  urgent release early plasma resuscitation following burn/thermal injury

• BiologicalStandard care

  Standard resuscitation as dictated by institutional protocol

Primary outcomes

1. 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.

   Time frame: 28 days

Secondary outcomes

1. 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)

   Time frame: 14 days

2. 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.

   Time frame: 7 days

3. 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

   Time frame: 7 days

4. Abdominal compartment syndrome

   Intra-abdominal hypertension requiring paralysis, and/or diagnostic peritoneal lavage, and/or decompressive laparotomy

   Time frame: Enrollment through hospital discharge or 28 days

5. In-hospital mortality

   Death prior to hospital discharge

   Time frame: Enrollment through hospital discharge or 28 days

6. 24-hour and 48-hour resuscitation

   All crystalloid, colloid (albumin) and plasma resuscitation, including the utilization of vitamin C

   Time frame: Enrollment through 24 hours and 48 hours

7. Acute kidney injury

   At least one instance of a serum creatinine ≥ 1.5

   Time frame: Between 24 and 72 hours from the time of randomization

8. Nosocomial Infection

   CDC criteria for the diagnosis of hospital-acquired pneumonia and blood stream infection will be utilized

   Time frame: 28 days

9. 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.

   Time frame: 28 days

10. ICU- free days

    ICU-free days will be determined by subtracting the number of days where ICU admission was required from 28 days.

    Time frame: 28 days

11. 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.

    Time frame: Initial 12 hours from randomization

12. 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.

    Time frame: Starting at day of randomization and ending at day 28

Individual participant data

Plan to share: Yes — De-identified data may be shared with the funding agency as well as other researchers upon request to the Principal Investigator

Supporting information: Study protocol, Informed consent form

Time frame: Data will become available after publication of the primary manuscript

Access criteria: Requests for data will be submitted in writing and reviewed by the Principal Investigator.