UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026989 |
|---|---|
| Receipt number | R000030788 |
| Scientific Title | Impact of the Hybrid Emergency Room (ER) on Mortality in Severe Trauma |
| Date of disclosure of the study information | 2017/04/14 |
| Last modified on | 2017/04/13 19:49:09 |
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Basic information
Public title
Impact of the Hybrid Emergency Room (ER) on Mortality in Severe Trauma
Acronym
Impact of the Hybrid Emergency Room (ER) on Mortality in Severe Trauma
Scientific Title
Impact of the Hybrid Emergency Room (ER) on Mortality in Severe Trauma
Scientific Title:Acronym
Impact of the Hybrid Emergency Room (ER) on Mortality in Severe Trauma
Region
| Japan |
Condition
Condition
Trauma
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of Hybrid ER on mortality in patients with severe trauma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
28-day mortality
Key secondary outcomes
Cause of death, 24-hour mortality, ventilator-free days, ICU-free days, multiple organ distress syndrome, the Oxford Handicap Scale, total amount of administered crystalloid intravenous fluids, red blood cells, fresh frozen plasmas, and Platelets concentrates within first 24 hours, the existence of trauma's lethal triad, required time from patient arrival on the trauma resuscitation room to the beginning of CT and emergency surgery
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
injury severity score more than or equal to 16
transferred directly from the scene
Key exclusion criteria
transferred from other hospitals, referred to the department from ohter emergency rooms, treated in other emergency room, traumatic cardiopulmonary arrest on arrival, pediatric patients younger than 15 years of age, patients who were transferred to other hospitals for emergency surgery, penetrating trauma, and pregnant women
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuma Yamakawa |
Organization
Osaka General Medical Centre
Division name
Division of Trauma and Surgical Critical Care
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
k.yamakawa0911@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuma Yamakawa |
Organization
Osaka General Medical Centre
Division name
Division of Trauma and Surgical Critical Care
Zip code
Address
3-1-56 Bandai-Higashi, Sumiyoshi-ku, Osaka
TEL
06-6692-1201
Homepage URL
k.yamakawa0911@gmail.com
Sponsor or person
Institute
Division of Trauma and Surgical Critical Care, Osaka General Medical Centre
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪急性期・総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This was a retrospective historical control study conducted from August 2007 to July 2015 at the Osaka General Medical Center in Osaka, Japan.
Management information
Registered date
| 2017 | Year | 04 | Month | 13 | Day |
Last modified on
| 2017 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030788
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
