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Multiple Trauma/InjuriesREACT-2NCT01523626

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

A study testing Total body Computed Tomography. and Conventional imaging and selective CT scanning. in people with Multiple Trauma/Injuries, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Trauma/Injuries
What is being tested?
Total body Computed Tomography. and Conventional imaging and selective CT scanning.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,083 participants
Where
5 sitesin 2 countries
Study dates
Apr 2011to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Trauma patient with presence of one of the following criteria:
  • At least one of the following parameters at hospital arrival:
  • Respiratory rate ≥30/min or ≤10/min
  • Pulse ≥120/min;
  • Systolic blood pressure ≤100 mmHg
  • Estimated external blood loss ≥500 ml
Show all 20Show fewer
  • Glasgow Coma Score ≤13
  • Abnormal pupillary light reflex.
  • Or clinical suspicion of one of the following diagnoses:
  • Fractures from at least two long bones
  • Multiple rib fractures, flail chest or open chest
  • Severe abdominal injury
  • Pelvic fracture
  • Unstable vertebral fractures or signs of spinal cord injury.
  • Or one of the following injury mechanisms:
  • Fall from height (≥ 10 feet)
  • Ejection from the vehicle
  • Death occupant in same vehicle
  • Severely injured patient in same vehicle
  • Wedged or trapped chest / abdomen.

Who cannot join

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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Netherlands4 sites

  • Academic Medical Center (AMC)

    Amsterdam, 1105AZ

  • University Medical Center Groningen

    Groningen, 9700 RB

  • University Medical Centre Nijmegen

    Nijmegen, 6525 GA

  • Erasmus Medical Center

    Rotterdam, 3015 CE

Other trials in Netherlands

Switzerland1 site

  • University Hospital Basel

    Basel, CH - 4031

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
Total body Computed Tomography., Conventional imaging and selective CT scanning.
Keywords
Trauma, Injur*, Emergen*, Computed Tomography, Total body, TBCT, Whole body, WBCT, Full body, Pan CT
Medical subject headings
Multiple Trauma, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total body Computed Tomography.Other

    Also called Whole body CT, Pan CT, Full body CT, TBCT

    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.

  • Conventional imaging and selective CT scanning.Other

    Also called X-rays, FAST, Conventional radiography, Computed Tomography

    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.

Study groups in NCT01523626
Study groupRoleWhat they receive
Conventional imagingOtherThe control group will be evaluated with X-rays, ultrasonography and selective CT scanning.
Receives: Other: Conventional imaging and selective CT scanning.
Immediate total body CTOtherThe intervention group will receive a 'total body' CT scan from head to pelvis. Conventional radiography and FAST will be completely omitted.
Receives: Other: Total body Computed Tomography.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality.

    Mortality during hospital admission.

    Measured: From date of randomization until the date of death from any cause, while being an inpatient, assessed up to 1 year.

Secondary outcomes (7)

  1. Overall mortality

    Mortality in general during specific time frames.

    Measured: 24-hour, 30-day and 1-year mortality.

  2. Several clinical relevant time intervals.

    • time of arrival;
    • time to CT;
    • scanning time;
    • time to diagnosis;
    • time in the trauma room;
    • time to intervention.

    Measured: From date and time of randomization to date and time of immediate intervention or ICU arrival, with an expected duration of 1-3 hours.

  3. Radiation exposure

    Radiation dose in miliSievert.

    Measured: Until six months posttrauma.

  4. Quality of life

    As recorded by completing the EuroQol-6D.

    Measured: Six and twelve months posttrauma.

  5. Morbidity

    • complications and total number of (re-)interventions and re-admissions;
    • transfusion requirements;
    • length of ICU stay;
    • number of ventilation days.

    Measured: Up to six months posttrauma.

  6. General health

    As recorded by completing the HUI-3.

    Measured: Six and twelve months posttrauma.

  7. Cost-effectiveness analyses.

    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.

    Measured: Until six months posttrauma.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2012 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,083 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01523626
Sponsor's protocol ID
1711020323
Other IDs
NTR2607
Acronym
REACT-2
Status last verified
Feb 2018
First submitted
20 Jan 2012
Last updated
6 Feb 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Sethi D, Racioppi F, Baumgarten I, Bertollini R. Reducing inequalities from injuries in Europe. Lancet. 2006 Dec 23;368(9554):2243-50. doi: 10.1016/S0140-6736(06)68895-8.

    PubMed 17189036

  • 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.

  • Albrecht T, von Schlippenbach J, Stahel PF, Ertel W, Wolf KJ. [The role of whole body spiral CT in the primary work-up of polytrauma patients--comparison with conventional radiography and abdominal sonography]. Rofo. 2004 Aug;176(8):1142-50. doi: 10.1055/s-2004-813259. German.

    PubMed 15346611

  • Brenner DJ, Elliston CD. Estimated radiation risks potentially associated with full-body CT screening. Radiology. 2004 Sep;232(3):735-8. doi: 10.1148/radiol.2323031095. Epub 2004 Jul 23.

    PubMed 15273333

  • Deunk J, Brink M, Dekker HM, Kool DR, van Kuijk C, Blickman JG, van Vugt AB, Edwards MJ. Routine versus selective computed tomography of the abdomen, pelvis, and lumbar spine in blunt trauma: a prospective evaluation. J Trauma. 2009 Apr;66(4):1108-17. doi: 10.1097/TA.0b013e31817e55c3.

    PubMed 19359922

  • Fanucci E, Fiaschetti V, Rotili A, Floris R, Simonetti G. Whole body 16-row multislice CT in emergency room: effects of different protocols on scanning time, image quality and radiation exposure. Emerg Radiol. 2007 Feb;13(5):251-7. doi: 10.1007/s10140-006-0554-0. Epub 2006 Dec 20.

    PubMed 17180674

  • Gralla J, Spycher F, Pignolet C, Ozdoba C, Vock P, Hoppe H. Evaluation of a 16-MDCT scanner in an emergency department: initial clinical experience and workflow analysis. AJR Am J Roentgenol. 2005 Jul;185(1):232-8. doi: 10.2214/ajr.185.1.01850232.

    PubMed 15972429

  • Hilbert P, zur Nieden K, Hofmann GO, Hoeller I, Koch R, Stuttmann R. New aspects in the emergency room management of critically injured patients: a multi-slice CT-oriented care algorithm. Injury. 2007 May;38(5):552-8. doi: 10.1016/j.injury.2006.12.023.

    PubMed 17472791

  • Huber-Wagner S, Lefering R, Qvick LM, Korner M, Kay MV, Pfeifer KJ, Reiser M, Mutschler W, Kanz KG; Working Group on Polytrauma of the German Trauma Society. Effect of whole-body CT during trauma resuscitation on survival: a retrospective, multicentre study. Lancet. 2009 Apr 25;373(9673):1455-61. doi: 10.1016/S0140-6736(09)60232-4. Epub 2009 Mar 25.

    PubMed 19321199

  • Kalender WA, Seissler W, Klotz E, Vock P. Spiral volumetric CT with single-breath-hold technique, continuous transport, and continuous scanner rotation. Radiology. 1990 Jul;176(1):181-3. doi: 10.1148/radiology.176.1.2353088.

    PubMed 2353088

  • Kanz KG, Korner M, Linsenmaier U, Kay MV, Huber-Wagner SM, Kreimeier U, Pfeifer KJ, Reiser M, Mutschler W. [Priority-oriented shock trauma room management with the integration of multiple-view spiral computed tomography]. Unfallchirurg. 2004 Oct;107(10):937-44. doi: 10.1007/s00113-004-0845-4. German.

    PubMed 15452654

  • Kanz KG, Paul AO, Lefering R, Kay MV, Kreimeier U, Linsenmaier U, Mutschler W, Huber-Wagner S; Trauma Registry of the German Trauma Society. Trauma management incorporating focused assessment with computed tomography in trauma (FACTT) - potential effect on survival. J Trauma Manag Outcomes. 2010 May 10;4:4. doi: 10.1186/1752-2897-4-4.

    PubMed 20459713

  • Kim PK, Gracias VH, Maidment AD, O'Shea M, Reilly PM, Schwab CW. Cumulative radiation dose caused by radiologic studies in critically ill trauma patients. J Trauma. 2004 Sep;57(3):510-4. doi: 10.1097/01.ta.0000141028.97753.67.

    PubMed 15454795

  • Leidner B, Adiels M, Aspelin P, Gullstrand P, Wallen S. Standardized CT examination of the multitraumatized patient. Eur Radiol. 1998;8(9):1630-8. doi: 10.1007/s003300050601.

    PubMed 9866776

Questions about this trial

What is this clinical trial studying?

A study testing Total body Computed Tomography. and Conventional imaging and selective CT scanning. in people with Multiple Trauma/Injuries, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01523626, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.

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