A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:1/1/2014
Start Date:April 2011
End Date:March 2014
Contact:Johan C Goslings, PhD
Email:j.c.goslings@amc.nl
Phone:+31205666019

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Randomized Study of Early Assessment by CT Scanning in Trauma Patients

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.

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.

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.
We found this trial at
1
site
1504 Taub Loop
Houston, Texas 77030
(713) 873-2000
Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
?
mi
from
Houston, TX
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