Trauma Resuscitation With Low-Titer Group O Whole Blood or Products
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,100
- 试验地点
- 26
- 主要终点
- 6-hour Mortality
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of unseparated whole blood (referred to as Low-Titer Group O Whole Blood) and the separate components of whole blood (including red cells, plasma, platelets, and cryoprecipitate) in critically injured patients who require large-volume blood transfusions.
详细描述
Trauma is one of the leading causes of death in the United States, and disproportionately affects the young, killing those who might otherwise have lived long and productive lives. Injuries account for more years of potential life lost before age 75 than any other cause. Hemorrhage remains the most common cause of preventable death after injury, and blood transfusion is an essential part of treatment. Modern blood banking practices separate donated whole blood into components. The current standard of care in trauma transfusion is the balanced administration of equal numbers of units of blood components (packed red blood cells, plasma, and platelets), effectively attempting to reconstitute whole blood. A renewed approach to blood transfusion therapy in trauma is to use whole blood from the outset, which has not been separated. Compared with component therapy, whole blood offers several potential advantages, but there are only a small number of, mostly observational, studies comparing whole blood and component therapy, and they are very heterogeneous.
The TROOP trial will include injured adults with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (LTOWB) or blood components. This will allow a direct comparison to see if one type of transfusion is more strongly associated with improved clinical outcomes over the other.
The knowledge gained from this clinical trial will transform the way in which massively bleeding trauma patients are transfused. The trial is exceedingly well positioned to improve mortality from trauma and reduce the number of preventable deaths resulting from hemorrhagic shock.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Care providers will be blinded to assignment until the point of randomization, which is when the cooler is opened, in the trauma bay, to remove blood products for transfusion.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult trauma patient (estimated age > 15 or weight > 50 kg, if age unknown)
- •Patient taken to trauma center directly from scene
- •Commencement of blood transfusion (PRBC, plasma or LTOWB), in pre-hospital or in-hospital setting
- •Activation of site-specific Massive Hemorrhage Protocol or Massive Transfusion Protocol
- •Traumatic injury with at least one of the following:
- •Confirmed or suspected acute major bleeding
- •Assessment of Blood Consumption (ABC) Score ≥2
排除标准
- •Patients who have received, prehospital or in-hospital more than two units of LTOWB; the equivalent in components (two units of packed red blood cells and two units of plasma); or a combination of the two (more than one unit of LTOWB, one unit of packed cells, and one unit of plasma). Most trauma centers hold two units of either packed red blood cells (with two units of plasma) or two units of LTOWB in the emergency department. This stock is used to initiate transfusion, while the massive hemorrhage protocol is activated from the blood bank.
- •Patients transferred from another hospital
- •Children <15 years (in most communities, patients aged 15-18 years are treated at adult trauma centers, and patients in this age group frequently suffer life-threatening injuries, and will therefore be included)
- •Known prisoners, defined as individuals involuntarily confined or detained in a penal institution (including juvenile detention, involuntary psychiatric commitment, or court-ordered residential substance abuse treatment)
- •Moribund patients expected to die within 1 hour
- •Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)
- •Patients with known "do not resuscitate" orders prior to randomization
- •Patients who refuse the administration of blood products
- •Individuals with a research "opt out" bracelet.
- •Greater than 20% total body surface area (TBSA) burns
- •Suspected inhalation injury victims
- •Patients who are obviously pregnant on clinical examination or known to be pregnant as provided by the subject or legally authorized representative
研究组 & 干预措施
Components
Participants randomized to receive the component blood products.
干预措施: Components (Biological)
LTOWB
Participants randomized to receive (Low Titer O Whole Blood [LTOWB])
干预措施: LTOWB (Biological)
结局指标
主要结局
6-hour Mortality
时间窗: First 6 hours after randomization
Participant vital status at 6-hours following randomization (randomization defined as product container is opened for administration to participant)
次要结局
- 24-hour Mortality(First 24 hours after randomization)
- Hospital/30-day Mortality(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
- Incidence of Pre-specified Complications(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
- Incidence of major surgical procedures(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
- Length of Stay (Hospital and Intensive Care Unit)(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
- Adjudicated Primary Cause of Death(30-days post randomization)
- Hospital-, Ventilator- and Intensive Care Unit-free days(30-days post randomization)
- Time to hemostasis in those undergoing procedures with a hemostatic component(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
- Number and type of blood products used until hemostasis is achieved and from hemostasis to 24 hours after randomization(First 24 hours after randomization)
- Discharge destination(At hospital discharge or 30-days post randomization (whichever the earlier))
- Functional status(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
- Patient's quality of life(From randomization to hospital discharge or 30-days post randomization (whichever the earlier))
研究者
Jan O. Jansen
Principal Investigator
University of Alabama at Birmingham