Randomised study of Early Assessment by CT scanning in Trauma patients
| ISRCTN | ISRCTN55332315 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55332315 |
| Secondary identifying numbers | ZON-MW 3920.0005 |
- 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
Scientific
Trauma Unit AMC, G4-105
Postbus 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 5666019 |
|---|---|
| j.c.goslings@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | REACT Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2005 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1,124 |
| Key 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 |
| Key exclusion criteria | Excluded from analysis and comparison are: 1. Patients younger than 16 years of age 2. Death during transport to the hospital |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Trauma Unit AMC, G4-105
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Postbus 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| p.fungkonjin@amc.uva.nl | |
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Research council
The Netherlands Organization for Health Research and Development (Zon-Mw) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 1. study protocol | 22/08/2008 | Yes | No | |
| Results article | results | 01/01/2012 | Yes | No |
