A Prospective, Randomized Comparison of Fresh Frozen Plasma Versus Standard Crystalloid Intravenous Fluid as Initial Resuscitation Fluid
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number of Participants That Died Within 28 Days Post Injury
研究概览
简要总结
Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.
详细描述
Study Design: Severely injured trauma patients with a systolic blood pressure (SBP) ≤ 70 or SBP ≤ 90 with a heart rate ≥ 108 bpm at the scene will be enrolled and randomized to receive either 2 units of frozen plasma thawed in the field or normal saline (the current standard of care), as the initial resuscitation fluid. After this initial resuscitation fluid, both groups will receive the same standard of care, including packed red blood cells, additional normal saline, or plasma as needed based on laboratory and clinical evidence of coagulopathy. Blood samples and clinical information will be collected throughout the hospital stay up to 28 days after injury.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>=18 years
- •Acutely injured
- •SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.
排除标准
- •Visibly or verbally reported pregnant women
- •known prisoners
- •unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization)
- •known objection to blood products
- •the patient has an opt-out bracelet or, necklace or wallet card
- •a family member present at the scene objects to the patient's enrollment in research.
研究组 & 干预措施
Plasma
If the patient is randomized to experimental arm, 2 units of frozen type AB plasma (FP24) will be thawed in the Plasmatherm Dry Thawing and Warming Device according to the operator manual as approved by the FDA in the ambulance and infusion will commence as soon as the type AB plasma is ready, and will continue during transport to the emergency department (ED). After infusion of 2 units of type AB plasma is completed, subsequent care will proceed per institutional, Advanced Trauma Life Support (ATLS) guided resuscitation with acute packed red blood cells (pRBC) administration determined by the hemodynamic response and additional blood component administration guided by rapid thrombelastography (rTEG) and coagulation panel assessment in conjunction with clinical scenario.
干预措施: Type AB plasma (Biological)
Standard
If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute packed red blood cells pRBC administration determined by the hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.
干预措施: Crystalloid fluid (standard of care for resuscitation) (Drug)
结局指标
主要结局
Number of Participants That Died Within 28 Days Post Injury
时间窗: 28 days
death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)
次要结局
- Number of Participants With Admission Severe Coagulopathy(within 30 minutes of Emergency Department (ED) arrival)
- Composite Outcome of 28-day In-hospital Mortality and Postinjury Multiple Organ Failure (MOF) Incidence(28 days)
- Number of Participants With Admission Severe Acidosis(within 30 minutes of ED arrival)
- Admission Coagulopathy(within 30 minutes of Emergency Department (ED) arrival)
- Admission Clot Strength(within 30 minutes of ED arrival)
- Admission Acidosis(within 30 minutes of ED arrival)
研究者
Ernest E. Moore, MD
Professor and Vice Chair, Department of Surgery
Denver Health and Hospital Authority