Diagnostic efficacy and effectiveness of primary whole-body computed tomography (Pan-CT) in severe and multiple trauma
| ISRCTN | ISRCTN41462125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41462125 |
| Secondary identifying numbers | ukb/zkf_04/09 |
- Submission date
- 30/08/2009
- Registration date
- 18/09/2009
- Last edited
- 26/04/2012
- 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 Dirk Stengel
Scientific
Scientific
Centre for Clinical Research
Department of Trauma and Orthopaedic Surgery
Unfallkrankenhaus Berlin
Berlin
12683
Germany
| Phone | +49 3056813030 |
|---|---|
| dirk.stengel@ukb.de |
Study information
| Study design | PATRES-1: Retrospective diagnostic accuracy study PATRES-2: Prospective observational diagnostic effectiveness study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Other |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Primary whole-body computed tomography (Pan-CT) for Trauma Resuscitation Evaluation: a prospective diagnostic effectiveness trial with a retrospective diagnostic accuracy study |
| Study acronym | PATRES |
| Study objectives | Hypotheses (formulated as clinical rather than null-hypotheses): 1. Primary whole-body computed tomography (Pan-CT) is highly sensitive to exclude and highly specific to recognise life-threatening injuries in multiple trauma 2. Pan-CT significantly affects the clinical pre-test probability of certain injuries and influences clinical decision making |
| Ethics approval(s) | Approved by the Charité University Medical Centre in February 2009 |
| Health condition(s) or problem(s) studied | Blunt and penetrating multiple trauma |
| Intervention | PATRES-1: Hospital charts and RIS/PACS data of the patients will be studied retrospectively to determine diagnostic accuracy of Pan-CT. PATRES-2: Prospective observational study of patients undergoing Pan-CT. The diagnostic results will be assessed by comparing the initial clinical judgement, pre-test probability, and therapeutic plan of the trauma leader (an experienced trauma and orthopaedic surgeon who considers injury mechanism, clinical and ultrasound findings) immediately before Pan-CT, and after Pan-CT results. |
| Intervention type | Other |
| Primary outcome measure | PATRES-1: Accuracy of Pan-CT (i.e. sensitivity, specificity, area under the ROC curve) for diagnosing i) multiple trauma, ii) individual injuries. A synopsis of all diagnoses obtained during the hospital stay (e.g. CT-scans, clinical, intra-operative, and autopsy findings) will serve as the reference standard. All images will be re-read by experienced trauma radiologists, and hospital charts will independently be evaluated by trauma surgeons. PATRES-2: 1. Shift in the pre-test probability of the prevalence and severity of injuries as judged by trauma surgeons prior to and after Pan-CT 2. Related changes in clinical decision making (e.g., emergency surgery, transfer to intensive care unit [ICU]) |
| Secondary outcome measures | PATRES-1: 1. Rate of unnecessary CT-scans 2. Discrepancy between first and second readings PATRES-2: Perceived value and effectiveness of CT-scans by trauma leaders (immediately after availability of CT-scans [i.e. at the trauma bay]) |
| Overall study start date | 01/09/2009 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | PATRES-1: n=600, PATRES-2: n=100 |
| Key inclusion criteria | PATRES-1: Hospital charts and Radiology Information System/Picture Archiving and Communication System (RIS/PACS) data from consecutive male and female patients (no age limits) who i) had been admitted to the emergency department of a metropolitan trauma centre between 01/2008 and 06/2009 and ii) were referred to Pan-CT because of suspected multiple trauma by the physician on charge PATRES-2: Trauma leaders caring for consecutive male and female patients (no age limits) who are admitted to the emergency department of a metropolitan trauma centre and are referred to Pan-CT because of suspected multiple trauma |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Centre for Clinical Research
Berlin
12683
Germany
12683
Germany
Sponsor information
Unfallkrankenhaus Berlin Trauma Centre, Centre for Clinical Research (Germany)
Hospital/treatment centre
Hospital/treatment centre
Warener Str. 7
Berlin
12683
Germany
| Phone | +49 3056813030 |
|---|---|
| dirk.stengel@ukb.de | |
| Website | http://www.ukb.de/de/main/home_2.htm |
"ROR" |
https://ror.org/011zjcv36 |
Funders
Funder type
Other
Investigator-initiated trial without commercial funding. Study logistics and personnel will be provided by the Centre for Clinical Research of the Unfallkrankenhaus Berlin (Germany), and related costs will be covered by the investigator.
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? |
|---|---|---|---|---|---|
| Results article | retrospective cohort study results | 09/12/2011 | Yes | No |
