A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma

Background: 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 technically feasible and its usage is currently becoming common practice in several trauma centers. However, literature provides limited evidence whether immediate total-body CT 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 total-body CT scanning in trauma patients. Methods/design: The REACT-2 trial is an international, multicenter randomized clinical trial. All participating trauma centers have a multi-slice CT scanner located in the trauma room or at the Emergency Department (ED). All adult, nonpregnant, severely injured trauma patients according to predefined criteria will be included. Patients in whom direct scanning will hamper necessary cardiopulmonary resuscitation or who require an immediate operation because of imminent death (both as judged by the trauma team leader) are excluded. Randomization will be computer assisted. The intervention group will receive a contrast-enhanced total-body CT scan (head to pelvis) during the primary survey. The control group will be evaluated according to local conventional trauma imaging protocols (based on ATLS guidelines) supplemented with selective CT scanning. Primary outcome will be in-hospital mortality. Secondary outcomes are differences in mortality and morbidity during the first year post trauma, several trauma work-up time intervals, radiation exposure, general health and quality of life at 6 and 12 months post trauma and cost-effectiveness. Discussion: The REACT-2 trial is a multicenter randomized clinical trial that will provide evidence on the value of immediate total-body CT scanning during the primary survey of severely injured trauma patients. If immediate total-body CT scanning is found to be the best imaging strategy in severely injured trauma patients it could replace conventional imaging supplemented with CT in this specific group. Trial Registration: ClinicalTrials.gov: (NCT01523626). Background Injuries are the cause of 5.8 million deaths annually which accounts for almost 10% of global mortality [1]. Among adults aged 15-59 years the proportion of injuries as cause of death is even higher, ranging from 22% to 29% [1]. Injuries, whether unintentional or intentional, may have devastating effects on the lives of individuals and poses a great burden on public-health budgets [2]. This burden may even increase in the future, since the World Health Organization (WHO) projected a 28% increase in global deaths due to injury between 2004 and 2030 [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) * Correspondence: [email protected] Trauma Unit Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands Full list of author information is available at the end of the article Sierink et al. BMC Emergency Medicine 2012, 12:4 http://www.biomedcentral.com/1471-227X/12/4 © 2012 Sierink et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. guidelines which include a fast and priority-based physical examination as well as screening radiographs supplemented with selective Computed Tomography (CT) [3]. ATLS guidelines advise to routinely perform X-rays of thorax and pelvis and Focused Assessment with Sonography for Tauma (FAST) in trauma patients. X-rays of the spine and extremities are performed based on clinical suspicion during the secondary survey. 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 has become faster, more detailed and more available in the acute trauma care setting. CT shows high accuracy for a wide range of injuries [4-7] which is reflected by a low missed diagnosis rate [5,8-10]. 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 multi-detector 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 totalbody CT 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) where the trauma patient is admitted. The past assumption that total-body CT scanning 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 [11,12]. Several studies evaluated time intervals associated with totalbody CT usage in severely injured patients [4,5,8,13-18]. Time intervals focused on are scanning time, time to all diagnosis known and time in the ED. Some studies compare different scanning protocols [19-21], some evaluate the effects of a total-body CT scan in one group trauma patients [5,8,9], while others make a comparison in two cohorts trauma patients, one evaluated with an immediate total-body CT scan and one evaluated with ATLS based imaging protocols and selective CT scanning [22-25]. Although these studies are incomparable with respect to design, CT scanners used, diagnostic work-up protocols and trauma populations[26], the main conclusion is clear. Total-body CT 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. The most important question remains whether immediate total-body CT scanning will translate to improved clinical outcome. A recent study in 4621 trauma patients reported a significant increase in the probability of survival for patient given immediate total-body CT scanning compared with conventional imaging strategies supplemented with selective CT scanning [25]. However, since the study was retrospective in nature, no correction for all confounding variables could have been made. Patients who underwent immediate total-body CT scanning were on average more severely injured than those who did not receive total-body CT scanning. Differences between participating centers and protocols used for diagnostic work-up were not described. Whether the positive effect in survival in patients who underwent total-body CT scanning can be attributed solely to the total-body CT scan itself remains therefore unclear. Although literature provides limited evidence for the usage of an immediate total-body CT scan in the work-up of trauma patients, more and more trauma centers encourage and are implementing immediate total-body CT scanning in the diagnostic phase of primary trauma care. Since the burden of total-body CT scanning in terms of costs and radiation dose is at least controversial [20,27,28], the advantage of performing an immediate total-body CT scan should be proven in high quality studies resulting in high level evidence in order to make its implementation justifiable. In order to assess the value of immediate total-body CT scanning in severely injured trauma patients, the Academic Medical Center (AMC) in Amsterdam, the Netherlands, has initiated an international multicenter randomized controlled trial. Severely injured patients, who are thought to benefit the most from a total-body imaging concept, will be included. Such a trial has never been done before and is crucial to provide evidence whether or not the usage of immediate total-body CT scanning in the diagnostic phase of primary trauma care is justifiable.