ISRCTN ISRCTN55332315
DOI https://doi.org/10.1186/ISRCTN55332315
Protocol serial number ZON-MW 3920.0005
Sponsor Academic Medical Center (AMC) (The Netherlands)
Funder The Netherlands Organization for Health Research and Development (Zon-Mw) (Netherlands)
Submission date
12/09/2005
Registration date
12/09/2005
Last edited
02/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J.C. Goslings
Scientific

Trauma Unit AMC, G4-105
Postbus 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 5666019
Email j.c.goslings@amc.uva.nl

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study acronymREACT Trial
Study objectivesA 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedTrauma
InterventionPatients 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.
Intervention typeOther
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.

Key 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.

Completion date01/05/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration1124
Key inclusion criteriaAll 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
Key exclusion criteriaExcluded from analysis and comparison are:
1. Patients younger than 16 years of age
2. Death during transport to the hospital
Date of first enrolment01/11/2005
Date of final enrolment01/05/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Trauma Unit AMC, G4-105
Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2012 Yes No
Protocol article 1. study protocol 22/08/2008 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
Study website Study website 11/11/2025 11/11/2025 No Yes