Randomized Study of Early Assessment by CT Scanning in Trauma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,083
- 试验地点
- 5
- 主要终点
- In-hospital mortality.
研究概览
简要总结
Computed tomography (CT) scanning has become essential in the early diagnostic phase of trauma care because of its high diagnostic accuracy. The introduction of multi-slice CT scanners and infrastructural improvements made 'total body' CT scanning (TBCT) technically feasible and its usage is currently becoming common practice in several trauma centers.
However, literature provides limited evidence whether immediate 'total body' CT scanning leads to better clinical outcome then conventional radiographic imaging supplemented with selective CT scanning in trauma patients. The aim of the REACT-2 trial is to determine the value of immediate TBCT scanning in trauma patients.
The investigators hypothesize that immediate 'total body' CT scanning during the primary survey of severely injured trauma patients has positive effects on patient outcome compared with standard conventional ATLS based radiological imaging supplemented with selective CT scanning.
详细描述
Injuries are the cause of 5.8 million deaths annually which accounts for almost 10% of global mortality. Among adults aged 15-59 years the proportion of injuries as cause of death is even higher, ranging from 22% to 29% [1].
Specialized trauma centers all over the world provide initial trauma care and diagnostic work-up of trauma patients. This work-up is standardized and frequently based on the Advanced Trauma Life Support (ATLS) guidelines which include a fast and priority-based physical examination as well as screening radiographs supplemented with selective Computed Tomography scanning (CT). ATLS guidelines advise to routinely perform X-rays of thorax and pelvis and Focused Assessment with Sonography for Trauma (FAST) in trauma patients. Whether or not to perform CT scanning following conventional imaging is defined less clearly in the ATLS guidelines and depends upon national guidelines and local protocols.
In recent years CT scanning has become faster, more detailed and more available in the acute trauma care setting. CT shows high accuracy for a wide range of injuries which is reflected by a low missed diagnosis rate. Hence, the conventional radiological work-up according to the ATLS may not be the optimal choice of primary diagnostics anymore. Furthermore, severely injured patients frequently require secondary CT scanning of many parts of the body after conventional imaging. Modern multidetector CT scanners (MDCT) can perform imaging of the head, cervical spine, chest, abdomen and pelvis in a single examination ('total body' CT scanning). The past few years this 'total body' imaging concept gained popularity as a possible alternative to the conventional imaging strategy. With the use of immediate 'total body' CT (TBCT) scanning in trauma patients, rapid and detailed information of organ and tissue injury becomes available and a well-founded plan for further therapy can be made.
In the past, CT scanners were located in the radiology department, frequently even on another floor than the emergency department (ED) were the trauma patient is admitted. The past assumption that TBCT in severely injured trauma patients is too time consuming may no longer be held, since an increasing number of trauma centers have a CT scanner available at the ED or even in the trauma room itself. Several studies evaluated time intervals associated with TBCT usage in severely injured patients. Although these studies are incomparable with respect to design, CT scanners used, diagnostic work-up protocols and trauma populations, the main conclusion is clear. TBCT scanning in trauma patients is not as time consuming as was once expected and may even be time saving compared to conventional imaging protocols supplemented with selective CT.
More and more trauma centers encourage and are implementing immediate TBCT scanning in the diagnostic phase of primary trauma care. Since the burden of TBCT in terms of costs and radiation dose is at least controversial, the advantage of performing immediate TBCT should be proven in high quality studies resulting in high level evidence in order to make its implementation justifiable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Trauma patient with presence of one of the following criteria:
- •At least one of the following parameters at hospital arrival:
- •Respiratory rate ≥30/min or ≤10/min
- •Pulse ≥120/min;
- •Systolic blood pressure ≤100 mmHg
- •Estimated external blood loss ≥500 ml
- •Glasgow Coma Score ≤13
- •Abnormal pupillary light reflex.
- •Or clinical suspicion of one of the following diagnoses:
- •Fractures from at least two long bones
- •Multiple rib fractures, flail chest or open chest
- •Severe abdominal injury
- •Pelvic fracture
- •Unstable vertebral fractures or signs of spinal cord injury.
- •Or one of the following injury mechanisms:
- •Fall from height (≥ 10 feet)
- •Ejection from the vehicle
- •Death occupant in same vehicle
- •Severely injured patient in same vehicle
- •Wedged or trapped chest / abdomen.
排除标准
- •Age <18 years (if known)
- •Known pregnancy
- •Patients referred from other hospitals
- •Clearly low-energy trauma with blunt injury mechanism
- •Penetrating injury in 1 body region (except gun shot wounds) as the clearly isolated injury
- •Any patient who is judged to be too unstable to undergo a CT scan and requires (cardiopulmonary) resuscitation or immediate operation because death is imminent.
研究组 & 干预措施
Conventional imaging
The control group will be evaluated with X-rays, ultrasonography and selective CT scanning.
干预措施: Conventional imaging and selective CT scanning. (Other)
Immediate total body CT
The intervention group will receive a 'total body' CT scan from head to pelvis. Conventional radiography and FAST will be completely omitted.
干预措施: Total body Computed Tomography. (Other)
结局指标
主要结局
In-hospital mortality.
时间窗: From date of randomization until the date of death from any cause, while being an inpatient, assessed up to 1 year.
Mortality during hospital admission.
次要结局
- Overall mortality(24-hour, 30-day and 1-year mortality.)
- Morbidity(Up to six months posttrauma.)
- General health(Six and twelve months posttrauma.)
- Cost-effectiveness analyses.(Until six months posttrauma.)
- Radiation exposure(Until six months posttrauma.)
- Several clinical relevant time intervals.(From date and time of randomization to date and time of immediate intervention or ICU arrival, with an expected duration of 1-3 hours.)
- Quality of life(Six and twelve months posttrauma.)
研究者
J.C. Goslings
Clinical Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
