Health TrialsbyHealthPanel

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

ConditionsBurn InjuryThermal Burn
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJason Sperry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth

Anticipated admission to burn ICU

Disqualifiers

Estimated rBaux score <55

Not expected to survive >24 hours

Wearing NO PREEVENT opt-out bracelet

Age > 75 or < 18 years of age

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plasma

    Biological/Vaccine

    urgent release early plasma resuscitation following burn/thermal injury

  • Standard care

    Biological/Vaccine

    Standard resuscitation as dictated by institutional protocol

Treatment groups

750 Participants
are divided into 2 treatment groups
Group A: Early Plasma ResuscitationExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jason Sperry

Lead sponsor

University of Pittsburgh

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
Apply now