Condition category
Injury, Occupational Diseases, Poisoning
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
02/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.reacttrial.nl

Contact information

Type

Scientific

Primary contact

Dr J.C. Goslings

ORCID ID

Contact details

Trauma Unit AMC
G4-105
Postbus 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 5666019
j.c.goslings@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZON-MW 3920.0005

Study information

Scientific title

Acronym

REACT Trial

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Trauma

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/11/2005

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1,124

Participant exclusion criteria

Excluded from analysis and comparison are:
1. Patients younger than 16 years of age
2. Death during transport to the hospital

Recruitment start date

01/11/2005

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trauma Unit AMC, G4-105
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Postbus 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 9111
p.fungkonjin@amc.uva.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

The Netherlands Organization for Health Research and Development (Zon-Mw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Saltzherr TP, Bakker FC, Beenen LF, Dijkgraaf MG, Reitsma JB, Goslings JC, , Randomized clinical trial comparing the effect of computed tomography in the trauma room versus the radiology department on injury outcomes., Br J Surg, 2012, 99 Suppl 1, 105-113, doi: 10.1002/bjs.7705.

  2. Saltzherr TP, Fung Kon Jin PH, Bakker FC, Ponsen KJ, Luitse JS, Scholing M, Giannakopoulos GF, Beenen LF, Henny CP, Koole GM, Reitsma HB, Dijkgraaf MG, Bossuyt PM, Goslings JC, An evaluation of a Shockroom located CT scanner: a randomized study of early assessment by CT scanning in trauma patients in the bi-located trauma center North-West Netherlands (REACT trial)., BMC Emerg Med, 2008, 8, 10, doi: 10.1186/1471-227X-8-10.

Additional files

Editorial Notes