Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Jason Sperry
- 入组人数
- 750
- 试验地点
- 2
- 主要终点
- 28-day Mortality or Persistent Organ Dysfunction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated ≥ 20% Total Body Surface Area burn/thermal injury with 2nd or 3rd degree depth
- •Anticipated admission to burn ICU
排除标准
- •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
研究组 & 干预措施
Standard Care
Subjects will receive resuscitation following individual site standard burn resuscitation practice.
干预措施: Standard care (Biological)
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)%.
干预措施: Plasma (Biological)
结局指标
主要结局
28-day Mortality or Persistent Organ Dysfunction
时间窗: 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.
次要结局
- 14-day mortality or Persistent Organ Dysfunction(14 days)
- Arterial or venous thromboembolism in first 7 days(7 days)
- Acute respiratory distress syndrome (ARDS) in first 7 days(7 days)
- Abdominal compartment syndrome(Enrollment through hospital discharge or 28 days)
- In-hospital mortality(Enrollment through hospital discharge or 28 days)
- 24-hour and 48-hour resuscitation(Enrollment through 24 hours and 48 hours)
- Acute kidney injury(Between 24 and 72 hours from the time of randomization)
- Nosocomial Infection(28 days)
- Ventilator-free days(28 days)
- ICU- free days(28 days)
- Allergic/transfusion reaction(Initial 12 hours from randomization)
- Persistent Organ Dysfunction (POD) Days(Starting at day of randomization and ending at day 28)