A Multicenter, Randomized Study of Early Assessment by CT Scanning in Severely Injured Trauma Patients
NCT01523626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1083
Last updated 2018-02-06
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
Interventions
- 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
-
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.
Sponsors & Collaborators
-
University Medical Center Nijmegen
collaborator OTHER - collaborator OTHER
-
University Medical Center Groningen
collaborator OTHER -
University Hospital, Basel, Switzerland
collaborator OTHER -
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Principal Investigators
-
J Carel Goslings, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-12-31
Countries
- Netherlands
- Switzerland
Study Locations
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