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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Medical Center Nijmegen
Erasmus Medical Center
University Medical Centre Groningen
Baylor College of Medicine
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01523626
First received: January 20, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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 Intervention
Immediate Total Body CT Scanning in Trauma Patients.
Other: Total body Computed Tomography.
Other: Conventional imaging and selective CT scanning.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Study of Early Assessment by CT Scanning in Trauma Patients

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Mortality during hospital admission.


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

  • 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. ] [ Designated as safety issue: No ]
    • time of arrival;
    • time to CT;
    • scanning time;
    • time to diagnosis;
    • time in the trauma room;
    • time to intervention.

  • Radiation exposure [ Time Frame: Until six months posttrauma. ] [ Designated as safety issue: No ]
    Radiation dose in miliSievert.

  • Quality of life [ Time Frame: Six and twelve months posttrauma. ] [ Designated as safety issue: No ]
    As recorded by completing the EuroQol-6D.

  • Morbidity [ Time Frame: Up to six months posttrauma. ] [ Designated as safety issue: No ]
    • complications and total number of (re-)interventions and re-admissions;
    • transfusion requirements;
    • length of ICU stay;
    • number of ventilation days.

  • General health [ Time Frame: Six and twelve months posttrauma. ] [ Designated as safety issue: No ]
    As recorded by completing the HUI-3.

  • Cost-effectiveness analyses. [ Time Frame: Until six months posttrauma. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 1078
Study Start Date: April 2011
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523626

Locations
Netherlands
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
Switzerland
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 Centre Groningen
Baylor College of Medicine
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Johan C Goslings, PhD Academic Medical Center, Amsterdam, The Netherlands
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J.C. Goslings, Clinical Professor, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01523626     History of Changes
Other Study ID Numbers: 1711020323, NTR2607
Study First Received: January 20, 2012
Last Updated: January 6, 2014
Health Authority: Netherlands: ZonMw, Netherlands Organisation for Health Research and Development
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United States: Institutional Review Board
Switzerland: Ethikkommission

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Trauma
Injur*
Emergen*
Computed Tomography
Total body
TBCT
Whole body
WBCT
Full body
Pan CT

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on August 27, 2014