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A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients (REACT-2)

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ClinicalTrials.gov Identifier: NCT01523626
Recruitment Status : Completed
First Posted : February 1, 2012
Last Update Posted : February 6, 2018
University Medical Center Nijmegen
Erasmus Medical Center
University Medical Center Groningen
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment Phase
Multiple Trauma/Injuries Other: Total body Computed Tomography. Other: Conventional imaging and selective CT scanning. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1083 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Study of Early Assessment by CT Scanning in Trauma Patients
Study Start Date : April 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Conventional imaging
The control group will be evaluated with X-rays, ultrasonography and selective CT scanning.
Other: Conventional imaging and selective CT scanning.

The control group will be evaluated according to a conventional trauma protocol with X-rays (of the chest and pelvis), ultrasonography (Focused Assessment with Sonography for Trauma (FAST)) and selective CT scanning.

Indications for the selective CT scanning are pre-defined and based on the combined local protocols of the participating centers.

Other Names:
  • X-rays
  • FAST
  • Conventional radiography
  • Computed Tomography
  • CT

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.
Other: Total body Computed Tomography.

The CT protocol for the intervention group consists of a two-step whole-body acquisition (from vertex to pubic symphysis) starting with Head and Neck Non Enhanced CT (NECT) with arms alongside the body.

The preferred technique for the second complementary scan is a split-bolus intravenous contrast directly after repositioning of the arms alongside the head, and this second scan covers thorax, abdomen and pelvis. Participating centers however are free to choose their own technique as long as intravenous contrast is given for the chest and abdominal part of the TBCT.

Other Names:
  • Whole body CT
  • Pan CT
  • Full body CT
  • TBCT
  • WBCT

Primary Outcome Measures :
  1. In-hospital mortality. [ Time Frame: 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.

Secondary Outcome Measures :
  1. Overall mortality [ Time Frame: 24-hour, 30-day and 1-year mortality. ]
    Mortality in general during specific time frames.

  2. Several clinical relevant time intervals. [ Time Frame: From date and time of randomization to date and time of immediate intervention or ICU arrival, with an expected duration of 1-3 hours. ]
    • time of arrival;
    • time to CT;
    • scanning time;
    • time to diagnosis;
    • time in the trauma room;
    • time to intervention.

  3. Radiation exposure [ Time Frame: Until six months posttrauma. ]
    Radiation dose in miliSievert.

  4. Quality of life [ Time Frame: Six and twelve months posttrauma. ]
    As recorded by completing the EuroQol-6D.

  5. Morbidity [ Time Frame: Up to six months posttrauma. ]
    • complications and total number of (re-)interventions and re-admissions;
    • transfusion requirements;
    • length of ICU stay;
    • number of ventilation days.

  6. General health [ Time Frame: Six and twelve months posttrauma. ]
    As recorded by completing the HUI-3.

  7. Cost-effectiveness analyses. [ Time Frame: Until six months posttrauma. ]

    Cost-effectiveness analyses will be performed with the costs per patient alive and costs per patient alive without serious morbidity as outcome measures.

    Additionally, a cost-utility analysis will be done with the cost per QALY as outcome measure. Incremental cost-effectiveness ratios will be calculated, expressing the extra costs per (i) extra patients alive, (ii) extra patients alive and without serious morbidity, and (iii) additional QALY.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523626

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Academic Medical Center (AMC)
Amsterdam, Netherlands, 1105AZ
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
University Medical Centre Nijmegen
Nijmegen, Netherlands, 6525 GA
Erasmus Medical Center
Rotterdam, Netherlands, 3015 CE
University Hospital Basel
Basel, Switzerland, CH - 4031
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University Medical Center Nijmegen
Erasmus Medical Center
University Medical Center Groningen
University Hospital, Basel, Switzerland
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Principal Investigator: J Carel Goslings, PhD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
World Health Organization. The global burden of disease: 2004 update. [http://www.who.int/healthinfo/global_burden_disease/2004_report_update/en/index.html]
American College of Surgeons Committee on Trauma.: ATLS advanced trauma life support program for doctors. Student Course Manual., 8th. edn. Chigago, IL: 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: J.C. Goslings, Clinical Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01523626    
Other Study ID Numbers: 1711020323
NTR2607 ( Registry Identifier: The Netherlands National Trial Register )
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Keywords provided by J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Computed Tomography
Total body
Whole body
Full body
Pan CT
Additional relevant MeSH terms:
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Wounds and Injuries
Multiple Trauma