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

NCT01523626 | Completed DMC

• 2 other identifiers: 1711020323NTR2607
• Study Type: interventional
• Target: 1,083
• Locations: 2 countries
• Sites: 5

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.

Conditions

Multiple Trauma/Injuries

Keywords

Trauma; Injur*; Emergen*; Computed Tomography; Total body; TBCT; Whole body; WBCT; Full body; Pan CT

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality.

  Mortality during hospital admission.

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

Secondary Outcomes (7)

• Overall mortality

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

• Several clinical relevant time intervals.

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

• Radiation exposure

  Until six months posttrauma.

• Quality of life

  Six and twelve months posttrauma.

• Morbidity

  Up to six months posttrauma.

Study Arms (2)

Conventional imaging

OTHER

The control group will be evaluated with X-rays, ultrasonography and selective CT scanning.

Other: Conventional imaging and selective CT scanning.

Immediate total body CT

OTHER

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.

Interventions

Total body Computed Tomography. OTHER

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.

Also known as: Whole body CT, Pan CT, Full body CT, TBCT, WBCT

Immediate total body CT

Conventional imaging and selective CT scanning. OTHER

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.

Also known as: X-rays, FAST, Conventional radiography, Computed Tomography, CT

Conventional imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• University Medical Center Nijmegen: collaborator
• Erasmus Medical Center: collaborator
• University Medical Center Groningen: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (5)

Academic Medical Center (AMC)

Amsterdam, 1105AZ, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Centre Nijmegen

Nijmegen, 6525 GA, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3015 CE, Netherlands

Location

University Hospital Basel

Basel, CH - 4031, Switzerland

Location

Related Publications (39)

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• Treskes K, Saltzherr TP, Edwards MJR, Beuker BJA, Den Hartog D, Hohmann J, Luitse JS, Beenen LFM, Hollmann MW, Dijkgraaf MGW, Goslings JC; REACT-2 study group. Emergency Bleeding Control Interventions After Immediate Total-Body CT Scans in Trauma Patients. World J Surg. 2019 Feb;43(2):490-496. doi: 10.1007/s00268-018-4818-0.

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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. Epub 2016 Jun 28.

  PMID: 27371185 DERIVED

• Hajibandeh S, Hajibandeh S. Systematic review: effect of whole-body computed tomography on mortality in trauma patients. J Inj Violence Res. 2015 Jul;7(2):64-74. doi: 10.5249/jivr.v7i2.613.

  PMID: 26104319 DERIVED

• Sierink JC, Saltzherr TP, Beenen LF, Luitse JS, Hollmann MW, Reitsma JB, Edwards MJ, Hohmann J, Beuker BJ, Patka P, Suliburk JW, Dijkgraaf MG, Goslings JC; REACT-2 study group. A multicenter, randomized controlled trial of immediate total-body CT scanning in trauma patients (REACT-2). BMC Emerg Med. 2012 Mar 30;12:4. doi: 10.1186/1471-227X-12-4.

  PMID: 22458247 DERIVED

MeSH Terms

Conditions

Multiple Trauma; Wounds and Injuries

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• J Carel Goslings, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: February 1, 2012
• Study Start: April 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

CH (1); NL (4)