| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000034928 |
| Receipt No. | R000039828 |
| Scientific Title | Prehospital quick sequential organ failure assessment score for predicting in-hospital mortality among patients with trauma: an analysis of nationwide registry data |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2019/06/26 (Ver. 8) |
| Basic information | ||
| Public title | Prehospital quick sequential organ failure assessment score for predicting in-hospital mortality among patients with trauma: an analysis of nationwide registry data | |
| Acronym | The association between the prehospital qSOFA score and in-hospital mortality in patients with trauma | |
| Scientific Title | Prehospital quick sequential organ failure assessment score for predicting in-hospital mortality among patients with trauma: an analysis of nationwide registry data | |
| Scientific Title:Acronym | The association between the prehospital qSOFA score and in-hospital mortality in patients with trauma | |
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| Condition | ||
| Condition | Trauma | |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To evaluate the discriminative ability of the prehospital qSOFA score for in-hospital mortality in patients with trauma |
| Basic objectives2 | Others |
| Basic objectives -Others | to evaluate the clinical prediction rule |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | in-hospital mortality |
| Key secondary outcomes | two-days mortality |
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| Study type | Observational |
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| Gender | Male and Female | |||
| Key inclusion criteria | trauma patients aged 18 and older who were registered between 2004 and 2016 in Japan Trauma Daba Bank | |||
| Key exclusion criteria | We excluded patients who had been transferred from other hospitals, presented with burn injuries, were <18 years old or exhibited cardiopulmonary arrest on the scene, as well as those with missing data for age, discharge outcome or vital signs at the scene, including the respiratory rate (RR), Japan Coma Scale (JCS) score or systolic blood pressure (SBP). | |||
| Target sample size | 40000 | |||
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| Organization | Wakayama Medical University | ||||||
| Division name | Department of Emergency and Critical Care Medicine | ||||||
| Zip code | 6418509 | ||||||
| Address | 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN | ||||||
| TEL | 0734410603 | ||||||
| gomadofu@wakayama-med.ac.jp | |||||||
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| Organization | Wakayama Medical University | ||||||
| Division name | Department of Emergency and Critical Care Medicine | ||||||
| Zip code | 6418509 | ||||||
| Address | 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN | ||||||
| TEL | 0734410603 | ||||||
| Homepage URL | |||||||
| gomadofu@wakayama-med.ac.jp | |||||||
| Sponsor | |
| Institute | Wakayama Medical University |
| Institute | |
| Department | |
| Funding Source | |
| Organization | Wakayama Medical University |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
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| IRB Contact (For public release) | |
| Organization | IRB of WMU |
| Address | Wakayama |
| Tel | 0734410603 |
| eccm@wakayama-med.ac.jp | |
| Secondary IDs | |
| Secondary IDs | NO |
| Study ID_1 | |
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| Related information | |
| URL releasing protocol | |
| Publication of results | Published |
| Result | |
| URL related to results and publications | https://www.ajemjournal.com/article/S0735-6757(19)30156-1/fulltext |
| Number of participants that the trial has enrolled | |
| Results | Objective The quick sequential organ failure assessment (qSOFA) score is calculated from three variables measured at the scene of trauma: systolic blood pressure, respiratory rate and consciousness. This study aimed to evaluate the discriminative ability of the prehospital qSOFA score for in-hospital mortality in patients with trauma. Methods This retrospective multicenter study used data from 42,722 patients with trauma included in a Japanese nationwide trauma registry. All included patients were aged >=18?years old and transferred to hospitals from the scenes of injury. The primary outcome was in-hospital mortality. Results The included patients had a mean age of 59.4?+-?21.5?years and a male predominance (63%). In-hospital mortality occurred in 2612 patients (6%), while 2-day mortality occurred in 1189 of 42,339 patients (3%). When patients were stratified by qSOFA scores, in-hospital mortality rates of 0.9% (105/11783), 5% (941/17839), 12% (1280/11132) and 15% (286/1968) were associated with qSOFA scores of 0, 1, 2 and 3, respectively (P?<?0.0001 for trend). The area under the receiver operating characteristics curve of the qSOFA score for in-hospital mortality was 0.70 (95% confidence interval: 0.69-0.71). A qSOFA score cutoff value >=1 yielded a sensitivity and specificity of 0.96 and 0.29, respectively, overall, and a sensitivity of 0.99 in patients younger than 65?years. Conclusions The prehospital qSOFA score was strongly associated with in-hospital mortality in patients with trauma. A prehospital qSOFA score cutoff of >=1 can be used to identify patients at a very low risk of death, especially in younger age groups. |
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| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | We analyze the data from the Japan Trauma Data Bank retrospectively. |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039828 |