Clinical trial NCT01523626: A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients
Official title: Randomized Study of Early Assessment by CT Scanning in Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Trauma/Injuries
Keywords: Trauma
Injur*
Emergen*
Computed Tomography
Total body
TBCT
Whole body
WBCT
Full body
Pan CT
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: University Medical Center Nijmegen
name: Erasmus Medical Center
name: University Medical Center Groningen
name: University Hospital, Basel, Switzerland
First posted: 2012-02-01
Enrollment: 1083
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

In order to assess the value of immediate TBCT scanning in severely injured trauma patients, the Academic Medical Center (AMC) in Amsterdam, the Netherlands, has initiated an international multicenter randomized clinical trial. Severely injured patients, who are thought to benefit the most from a 'total body' imaging concept, will be included.

Eligibility criteria: Inclusion Criteria:

Trauma patient with presence of one of the following criteria:

At least one of the following parameters at hospital arrival:

1. Respiratory rate ≥30/min or ≤10/min
2. Pulse ≥120/min;
3. Systolic blood pressure ≤100 mmHg
4. Estimated external blood loss ≥500 ml
5. Glasgow Coma Score ≤13
6. Abnormal pupillary light reflex.

Or clinical suspicion of one of the following diagnoses:

1. Fractures from at least two long bones
2. Multiple rib fractures, flail chest or open chest
3. Severe abdominal injury
4. Pelvic fracture
5. Unstable vertebral fractures or signs of spinal cord injury.

Or one of the following injury mechanisms:

1. Fall from height (≥ 10 feet)
2. Ejection from the vehicle
3. Death occupant in same vehicle
4. Severely injured patient in same vehicle
5. Wedged or trapped chest / abdomen.

Exclusion Criteria:

1. Age \<18 years (if known)
2. Known pregnancy
3. Patients referred from other hospitals
4. Clearly low-energy trauma with blunt injury mechanism
5. Penetrating injury in 1 body region (except gun shot wounds) as the clearly isolated injury
6. 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.

Primary outcomes:
measure: In-hospital mortality.
timeFrame: From date of randomization until the date of death from any cause, while being an inpatient, assessed up to 1 year.
Secondary outcomes:
measure: Overall mortality
timeFrame: 24-hour, 30-day and 1-year mortality.
measure: Several clinical relevant time intervals.
timeFrame: From date and time of randomization to date and time of immediate intervention or ICU arrival, with an expected duration of 1-3 hours.
measure: Radiation exposure
timeFrame: Until six months posttrauma.
measure: Quality of life
timeFrame: Six and twelve months posttrauma.
measure: Morbidity
timeFrame: Up to six months posttrauma.
measure: General health
timeFrame: Six and twelve months posttrauma.
measure: Cost-effectiveness analyses.
timeFrame: Until six months posttrauma.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nijmegen
country: Netherlands
facility: University Medical Centre Nijmegen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: J Carel Goslings, PhD
role: PRINCIPAL_INVESTIGATOR
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