Randomized study of Early Assessment by CT scanning in Trauma patients.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR86
• Date of registration: 05/08/2005
• Primary sponsor: Academic Medical Center (AMC)
• Public title: Randomized study of Early Assessment by CT scanning in Trauma patients.
• Scientific title: A randomized comparison of the bi-located Traumacenter North-West Netherlands, evaluating the presence of a Shockroom CT scanner on patient outcome and operations research. - REACT Trial
• Date of first enrolment: 1/11/2005
• Target sample size: 1124
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=86
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized

Countries of recruitment

The Netherlands

Contacts

• Name: J.C. Goslings

• Name: J.C. Goslings

Key inclusion & exclusion criteria

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.

Exclusion criteria: Excluded from analysis and comparison are:

1. Patients younger than 16 years of age;

2. Death during transport to the hospital.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Trauma

Intervention(s)

Patients are transported to either the VUmc or the AMC, based on randomization. Trauma care will remain the same for both institutions, with the only difference the location of the CT scanner.

Primary Outcome(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(s)

The secondary outcome parameters for the patient outcome part of the study will focus on:

1. The process of care parameters of the initial admission. This will include the comparison of various time intervals relevant in trauma care:

1.1 time to obtain results of CT imaging;

1.2 time to operation or other interventions (door-to-treatment time);

1.3 time to active bleed managing;

1.4 time to definitive care facility (ICU, high care, nursing ward);

1.5 duration of intensive care treatment;

1.6 time to discharge from the hospital;

2. Radiological examinations and findings:

2.1 The frequency and type of radiological examinations in each strategy;

2.2 description of the number, type and severity of diagnoses categorized by imaging modality in each strategy;

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

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

5. 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.

Secondary ID(s)

3920.0005

ISRCTN55332315

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development