|January 20, 2012
|December 23, 2014
|July 2014 (final data collection date for 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. ] [ Designated as safety issue: Yes ]
Mortality during hospital admission.
|Same as current
|Complete list of historical versions of study NCT01523626 on ClinicalTrials.gov Archive Site
- 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.
|Same as current
|A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients
|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% .
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Immediate Total Body CT Scanning in Trauma Patients.
- 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.
- Whole body CT
- Pan CT
- Full body CT
- 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.
- Conventional radiography
- Computed Tomography
- Conventional imaging
The control group will be evaluated with X-rays, ultrasonography and selective CT scanning.
Intervention: Other: Conventional imaging and selective CT scanning.
- 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.
Intervention: Other: Total body Computed Tomography.
- Sethi D, Racioppi F, Baumgarten I, Bertollini R. Reducing inequalities from injuries in Europe. Lancet. 2006 Dec 23;368(9554):2243-50.
- 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. German.
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- 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.
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- Kanz KG, Körner 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. German.
- 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.
- 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.
- Leidner B, Adiels M, Aspelin P, Gullstrand P, Wallén S. Standardized CT examination of the multitraumatized patient. Eur Radiol. 1998;8(9):1630-8.
- Linsenmaier U, Krötz M, Häuser H, Rock C, Rieger J, Bohndorf K, Pfeifer KJ, Reiser M. Whole-body computed tomography in polytrauma: techniques and management. Eur Radiol. 2002 Jul;12(7):1728-40.
- Löw R, Düber C, Schweden F, Lehmann L, Blum J, Thelen M. [Whole body spiral CT in primary diagnosis of patients with multiple trauma in emergency situations]. Rofo. 1997 May;166(5):382-8. German.
- Maurer MH, Knopke S, Schröder RJ. [Added diagnostic benefit of 16-row whole-body spiral CT in patients with multiple trauma differentiated by region and injury severity according to the ATLS concept]. Rofo. 2008 Dec;180(12):1117-23. doi: 10.1055/s-2008-1027851. German.
- Nguyen D, Platon A, Shanmuganathan K, Mirvis SE, Becker CD, Poletti PA. Evaluation of a single-pass continuous whole-body 16-MDCT protocol for patients with polytrauma. AJR Am J Roentgenol. 2009 Jan;192(1):3-10. doi: 10.2214/AJR.07.3702.
- Philipp MO, Kubin K, Hörmann M, Metz VM. Radiological emergency room management with emphasis on multidetector-row CT. Eur J Radiol. 2003 Oct;48(1):2-4. Review.
- Prokop A, Hötte H, Krüger K, Rehm KE, Isenberg J, Schiffer G. [Multislice CT in diagnostic work-up of polytrauma]. Unfallchirurg. 2006 Jul;109(7):545-50. German.
- Ptak T, Rhea JT, Novelline RA. Radiation dose is reduced with a single-pass whole-body multi-detector row CT trauma protocol compared with a conventional segmented method: initial experience. Radiology. 2003 Dec;229(3):902-5.
- Rieger M, Sparr H, Esterhammer R, Fink C, Bale R, Czermak B, Jaschke W. [Modern CT diagnosis of acute thoracic and abdominal trauma]. Anaesthesist. 2002 Oct;51(10):835-42. Review. German.
- Rieger M, Czermak B, El Attal R, Sumann G, Jaschke W, Freund M. Initial clinical experience with a 64-MDCT whole-body scanner in an emergency department: better time management and diagnostic quality? J Trauma. 2009 Mar;66(3):648-57. doi: 10.1097/TA.0b013e31816275f3.
- Ruchholtz S, Waydhas C, Schroeder T, Piepenbrink K, Kühl H, Nast-Kolb D. [The value of computed tomography in the early treatment of seriously injured patients]. Chirurg. 2002 Oct;73(10):1005-12. German.
- Salim A, Sangthong B, Martin M, Brown C, Plurad D, Demetriades D. Whole body imaging in blunt multisystem trauma patients without obvious signs of injury: results of a prospective study. Arch Surg. 2006 May;141(5):468-73; discussion 473-5.
- Saltzherr TP, Goslings JC; multidisciplinary REACT 2 study group.. Effect on survival of whole-body CT during trauma resuscitation. Lancet. 2009 Jul 18;374(9685):198; author reply 198-9. doi: 10.1016/S0140-6736(09)61324-6.
- Sampson MA, Colquhoun KB, Hennessy NL. Computed tomography whole body imaging in multi-trauma: 7 years experience. Clin Radiol. 2006 Apr;61(4):365-9.
- Smith CM, Woolrich-Burt L, Wellings R, Costa ML. Major trauma CT scanning: the experience of a regional trauma centre in the UK. Emerg Med J. 2011 May;28(5):378-82. doi: 10.1136/emj.2009.076414.
- Tien HC, Tremblay LN, Rizoli SB, Gelberg J, Spencer F, Caldwell C, Brenneman FD. Radiation exposure from diagnostic imaging in severely injured trauma patients. J Trauma. 2007 Jan;62(1):151-6.
- Weninger P, Mauritz W, Fridrich P, Spitaler R, Figl M, Kern B, Hertz H. Emergency room management of patients with blunt major trauma: evaluation of the multislice computed tomography protocol exemplified by an urban trauma center. J Trauma. 2007 Mar;62(3):584-91.
- Wurmb T, Frühwald P, Brederlau J, Steinhübel B, Frommer M, Kuhnigk H, Kredel M, Knüpffer J, Hopfner W, Maroske J, Moll R, Wagner R, Thiede A, Schindler G, Roewer N. [The Würzburg polytrauma algorithm. Concept and first results of a sliding-gantry-based computer tomography diagnostic system]. Anaesthesist. 2005 Aug;54(8):763-8; 770-2. German.
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- Sierink JC, Treskes K, Edwards MJ, Beuker BJ, den Hartog D, Hohmann J, Dijkgraaf MG, Luitse JS, Beenen LF, Hollmann MW, Goslings JC; REACT-2 study group.. Immediate total-body CT scanning versus conventional imaging and selective CT scanning in patients with severe trauma (REACT-2): a randomised controlled trial. Lancet. 2016 Aug 13;388(10045):673-83. doi: 10.1016/S0140-6736(16)30932-1.
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|July 2014 (final data collection date for primary outcome measure)
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
- 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.
- 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.
|18 Years and older (Adult, Senior)
|Contact information is only displayed when the study is recruiting subjects
|J.C. Goslings, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- University Medical Center Nijmegen
- Erasmus Medical Center
- University Medical Center Groningen
- University Hospital, Basel, Switzerland
||J Carel Goslings, PhD
||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)