Joanne C Sierink1, Kaij Treskes1, Michael J R Edwards2, Benn J A Beuker3, Dennis den Hartog4, Joachim Hohmann5, Marcel G W Dijkgraaf6, Jan S K Luitse1, Ludo F M Beenen7, Markus W Hollmann8, J Carel Goslings9. 1. Trauma Unit, Department of Surgery, Academic Medical Center, Amsterdam, Netherlands. 2. Trauma Unit, Department of Surgery, Radboud University Medical Center, Nijmegen, Netherlands. 3. Trauma Unit, Department of Surgery, University Medical Center Groningen, Groningen, Netherlands. 4. Trauma Research Unit, Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, Netherlands. 5. Department of Radiology and Nuclear Medicine, University of Basel Hospital, Basel, Switzerland. 6. Clinical Research Unit, Academic Medical Center, Amsterdam, Netherlands. 7. Department of Radiology, Academic Medical Center, Amsterdam, Netherlands. 8. Department of Anaesthesiology, Academic Medical Center, Amsterdam, Netherlands. 9. Trauma Unit, Department of Surgery, Academic Medical Center, Amsterdam, Netherlands. Electronic address: j.c.goslings@amc.nl.
Abstract
BACKGROUND: Published work suggests a survival benefit for patients with trauma who undergo total-bodyCT scanning during the initial trauma assessment; however, level 1 evidence is absent. We aimed to assess the effect of total-body CT scanning compared with the standard work-up on in-hospital mortality in patients with trauma. METHODS: We undertook an international, multicentre, randomised controlled trial at four hospitals in the Netherlands and one in Switzerland. Patients aged 18 years or older with trauma with compromised vital parameters, clinical suspicion of life-threatening injuries, or severe injury were randomly assigned (1:1) by ALEA randomisation to immediate total-body CT scanning or to a standard work-up with conventional imaging supplemented with selective CT scanning. Neither doctors nor patients were masked to treatment allocation. The primary endpoint was in-hospital mortality, analysed in the intention-to-treat population and in subgroups of patients with polytrauma and those with traumatic brain injury. The χ(2) test was used to assess differences in mortality. This trial is registered with ClinicalTrials.gov, number NCT01523626. FINDINGS:Between April 22, 2011, and Jan 1, 2014, 5475 patients were assessed for eligibility, 1403 of whom were randomly assigned: 702 toimmediate total-body CT scanning and 701 to the standard work-up. 541 patients in the immediate total-body CT scanning group and 542 in the standard work-up group were included in the primary analysis. In-hospital mortality did not differ between groups (total-body CT 86 [16%] of 541 vs standard work-up 85 [16%] of 542; p=0.92). In-hospital mortality also did not differ between groups in subgroup analyses in patients with polytrauma (total-body CT 81 [22%] of 362 vs standard work-up 82 [25%] of 331; p=0.46) and traumatic brain injury (68 [38%] of 178 vs 66 [44%] of 151; p=0.31). Three serious adverse events were reported in patients in the total-body CT group (1%), one in the standard work-up group (<1%), and one in a patient who was excluded after random allocation. All five patients died. INTERPRETATION: Diagnosing patients with animmediate total-body CT scan does not reduce in-hospital mortality compared with the standard radiological work-up. Because of the increased radiation dose, future research should focus on the selection of patients who will benefit from immediate total-body CT. FUNDING: ZonMw, the Netherlands Organisation for Health Research and Development.
RCT Entities:
BACKGROUND: Published work suggests a survival benefit for patients with trauma who undergo total-body CT scanning during the initial trauma assessment; however, level 1 evidence is absent. We aimed to assess the effect of total-body CT scanning compared with the standard work-up on in-hospital mortality in patients with trauma. METHODS: We undertook an international, multicentre, randomised controlled trial at four hospitals in the Netherlands and one in Switzerland. Patients aged 18 years or older with trauma with compromised vital parameters, clinical suspicion of life-threatening injuries, or severe injury were randomly assigned (1:1) by ALEA randomisation to immediate total-body CT scanning or to a standard work-up with conventional imaging supplemented with selective CT scanning. Neither doctors nor patients were masked to treatment allocation. The primary endpoint was in-hospital mortality, analysed in the intention-to-treat population and in subgroups of patients with polytrauma and those with traumatic brain injury. The χ(2) test was used to assess differences in mortality. This trial is registered with ClinicalTrials.gov, number NCT01523626. FINDINGS: Between April 22, 2011, and Jan 1, 2014, 5475 patients were assessed for eligibility, 1403 of whom were randomly assigned: 702 to immediate total-body CT scanning and 701 to the standard work-up. 541 patients in the immediate total-body CT scanning group and 542 in the standard work-up group were included in the primary analysis. In-hospital mortality did not differ between groups (total-body CT 86 [16%] of 541 vs standard work-up 85 [16%] of 542; p=0.92). In-hospital mortality also did not differ between groups in subgroup analyses in patients with polytrauma (total-body CT 81 [22%] of 362 vs standard work-up 82 [25%] of 331; p=0.46) and traumatic brain injury (68 [38%] of 178 vs 66 [44%] of 151; p=0.31). Three serious adverse events were reported in patients in the total-body CT group (1%), one in the standard work-up group (<1%), and one in a patient who was excluded after random allocation. All five patients died. INTERPRETATION: Diagnosing patients with an immediate total-body CT scan does not reduce in-hospital mortality compared with the standard radiological work-up. Because of the increased radiation dose, future research should focus on the selection of patients who will benefit from immediate total-body CT. FUNDING: ZonMw, the Netherlands Organisation for Health Research and Development.
Authors: L Grünherz; K O Jensen; V Neuhaus; L Mica; C M L Werner; B Ciritsis; C Michelitsch; G Osterhoff; H-P Simmen; K Sprengel Journal: Eur J Trauma Emerg Surg Date: 2017-07-20 Impact factor: 3.693