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Randomised study of Early Assessment by CT scanning in Trauma patients
DOI 10.1186/ISRCTN55332315
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised study of Early Assessment by CT scanning in Trauma patients
Scientific title
Acronym REACT Trial
Serial number at source ZON-MW 3920.0005
Study hypothesis A trauma care strategy involving early shockroom CT scanning with a standard diagnostic imaging strategy in trauma patients has a positive effect on both patient outcome and operations research.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Trauma
Participants - inclusion criteria All patients that are transported to the AMC or VUmc shockroom according to current pre-hospital triage system based on:
1. Injury mechanism
2. Revised Trauma Score
3. Presence or absence of traumatic brain injury
Participants - exclusion criteria Excluded from analysis and comparison are:
1. Patients younger than 16 years of age
2. Death during transport to the hospital
Anticipated start date 01/11/2005
Anticipated end date 01/05/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1,124
Interventions Patients are transported to either the VUmc or the AMC, based on randomisation. Trauma care will remain the same for both institutions, with the only difference the location of the CT scanner.
Primary outcome measure(s) The number of days spent outside the hospital in the first year following the emergency admission in the shockroom will be our primary outcome. This outcome is responsive to differences in mortality (no more/additional days outside hospital), to differences in hospital stay for the initial admission, to differences in readmission rate (i.e. because of missed diagnoses). Furthermore, there is a positive association between a shorter hospital stay and better functional health. Care will be given to harmonize discharge criteria between the two hospitals.
Secondary outcome measure(s) The secondary outcome parameters for the patient outcome part of the study will focus on:

- The process of care parameters of the initial admission. This will include the comparison of various time intervals relevant in trauma care:
1. time to obtain results of CT imaging
2. time to operation or other interventions (door-to-treatment time)
3. time to active bleed managing
4. time to definitive care facility (ICU, high care, nursing ward)
5. duration of intensive care treatment
6. time to discharge from the hospital

- Radiological examinations and findings:
1. the frequency and type of radiological examinations in each strategy
2. description of the number, type and severity of diagnoses categorized by imaging modality in each strategy

- General health. This will be measured in all patients at 6 and 12 months after the shockroom admission using the EuroQol and HUI3 questionnaires.

- All-cause mortality. This will include both in-hospital mortality and mortality during the first year following the trauma.

- Radiation dose. The mean radiation dose will be calculated in both strategies based on the actual number and type of radiological examinations related to the initial trauma performed in each patient during the first year.
Sources of funding The Netherlands Organization for Health Research and Development (Zon-Mw) (Netherlands)
Trial website http://www.reacttrial.nl
Publications 1.2008 study protocol in http://www.ncbi.nlm.nih.gov/pubmed/18721455
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22441863
Contact name Dr  J.C.  Goslings
  Address Trauma Unit AMC, G4-105
Postbus 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 5666019
  Email j.c.goslings@amc.uva.nl
Sponsor Academic Medical Center (AMC) (The Netherlands)
  Address Postbus 22660
  City/town Amsterdam
  Zip/Postcode 1100 DD
  Country Netherlands
  Tel +31 (0)20 566 9111
  Email p.fungkonjin@amc.uva.nl
Date applied 12/09/2005
Last edited 02/05/2012
Date ISRCTN assigned 12/09/2005
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