One size does not fit all: is whole-body computed tomography beneficial for all patients with suspected major trauma?
| ISRCTN | ISRCTN32471051 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32471051 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Researchregistry11185 |
| Sponsor | Linkou Chang Gung Memorial Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 04/11/2025
- Registration date
- 05/11/2025
- Last edited
- 05/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Whole-body computed tomography (WBCT) has become a common imaging tool for major trauma patients, potentially improving diagnostic speed and clinical outcomes. However, its benefits over conventional imaging protocol remain debated due to concerns such as increased radiation exposure and resource utilization. This study aimed to compare WBCT and conventional imaging in major trauma patients to assess differences in diagnostic efficiency, radiation exposure, and clinical outcomes.
Who can participate?
Patients aged 16 to 80 years admitted directly to our emergency department (ED) with major or multiple traumas
What does the study involve?
Participants were randomly allocated to either WBCT or conventional imaging (X-rays and CT scans). Data collected included demographics, injury severity, time intervals from arrival to diagnosis and decision-making, radiation dose, complications, and death rates.
What are the possible benefits and risks of participating?
Possible benefits:
1. Participants may receive faster or more comprehensive diagnostic imaging through WBCT, which could improve diagnostic efficiency and clinical decision-making.
2. The study could contribute to improved trauma care protocols in the future.
Possible risks:
1. WBCT involves higher radiation exposure compared to conventional imaging.
2. There is a small risk associated with contrast media (mild allergic reactions).
3. Transporting unstable patients to the CT room may pose minimal but recognized clinical risks; however, the hospital has established protocols to ensure safety.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
May 2011 to February 2012
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Erh-Hao Liu
Contact information
Public, Scientific, Principal investigator
No.6, Sec.2
Jincheng Road.
Tucheng Dist.
New Taipei City
236
Taiwan
| Phone | +886 (0)2 22630588 ext 6262 |
|---|---|
| m7017@cgmh.org.tw |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | One size does not fit all: is whole-body computed tomography beneficial for all patients with suspected major trauma? A prospective randomized controlled trial |
| Study objectives | Whole-body computed tomography (WBCT) has become a common imaging tool for major trauma patients, potentially improving diagnostic speed and clinical outcomes. However, its benefits over conventional imaging protocol remain debated due to concerns such as increased radiation exposure and resource utilization. This study aimed to compare WBCT and conventional imaging protocol in major trauma patients to assess differences in diagnostic efficiency, radiation exposure, and clinical outcomes. |
| Ethics approval(s) |
Approved 02/05/2011, The Institutional Review Board (IRB) of Chang Gung Memorial Hospital (No. 123, Dinghu Rd., Jiulu Village, Guishan District, Taoyuan City, 333, Taiwan; +886 (0)3-3196200 ext 3706; violet1202@cgmh.org.tw), ref: 98-3483A3 |
| Health condition(s) or problem(s) studied | Major trauma |
| Intervention | This study randomly assigned trauma patients to either a WBCT (whole-body CT) group or a conventional imaging group. All patients who met the selection criteria were referred to a randomization sheet. Each case was assigned a number in sequence and then allocated to the corresponding group based on the group label associated with that number on the sheet. The randomization sheet was created by printing lots (managed by Erh-Hao Liu) that were evenly distributed and labeled as either "experimental" or "control." Each number was assigned a group sequentially based on the order in which the lots were drawn. The WBCT group received whole-body CT as the first-line imaging, while the control group underwent standard radiography and sonography, including FAST and plain films. Focused CT scans were used as needed based on initial findings. Both groups were further divided into three subgroups: unstable (with abnormal vital signs), unconscious (GCS <13 but stable vitals), and mechanism-related (stable and alert but with significant injury mechanisms). This design allowed for comparison of imaging strategies across varying trauma severities and patient conditions. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Pre-hospital time: time from the accident to the patient’s arrival at the ER |
| Key secondary outcome measure(s) |
Subgroup analyses comparison: Unstable, Unconscious, and Mechanism-related groups |
| Completion date | 21/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 486 |
| Total final enrolment | 151 |
| Key inclusion criteria | Patients admitted directly to our emergency department (ED) who met the trauma team activation criteria were considered candidates for major or multiple traumas. The criteria included one or more of the following: 1. Unstable vital signs: 1.1. Systolic blood pressure <90 mmHg 1.2. Respiratory rate >29 or <10 2. Conscious disturbance: 2.1. Glasgow Coma Scale (GCS) <13 3. Trauma mechanisms: 3.1. Falls from a height >6 meters 3.2. Pedestrian struck by a vehicle 3.3. Heavy object crush injury 3.4. Ejection from a vehicle 3.5. Death of another passenger in the same event 3.6. Extreme age (<10 or >65 years) in cases of multiple trauma |
| Key exclusion criteria | 1. Under 16 years of age 2. Pregnant 3. Referrals from other hospitals 4 .Suspected of drowning 5. Experiencing traumatic cardiac arrest (TCA) without return of spontaneous circulation (ROSC) 6. Solitary burn injuries 7. Clearly isolated focal injuries |
| Date of first enrolment | 02/05/2011 |
| Date of final enrolment | 21/02/2012 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Jiulu Village
Guishan District
Taoyuan City
333
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data supporting this study contain sensitive personal information and cannot be made publicly available. Data may be shared by the corresponding author upon reasonable request and with appropriate ethical approval. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/11/2025: Study's existence confirmed by the Institutional Review Board (IRB) of Chang Gung Memorial Hospital.
