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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034042 |
Receipt No. | R000038808 |
Scientific Title | Severity by stress index among trauma patients |
Date of disclosure of the study information | 2018/09/05 |
Last modified on | 2020/09/07 |
Basic information | ||
Public title | Severity by stress index among trauma patients | |
Acronym | severity stress index trauma | |
Scientific Title | Severity by stress index among trauma patients | |
Scientific Title:Acronym | severity stress index trauma | |
Region |
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Condition | ||
Condition | trauma | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study was to identify and validate prediction models of severe trauma (ST), needs of damage control operation (DCOP), and massive transfusion (MT) by using SI among trauma patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Survival to discharge |
Key secondary outcomes | Trauma severity |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Trauma patient admitted to an emergency room. | |||
Key exclusion criteria | Non trauma patients | |||
Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Yokohama City University | ||||||
Division name | Medical Center | ||||||
Zip code | 232-0024 | ||||||
Address | 4-57 Urafunecho, Minamiku, Yokohama | ||||||
TEL | 045-261-5656 | ||||||
takeru-a@umin.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Yokohama City University | ||||||
Division name | Medical Center | ||||||
Zip code | 232-0024 | ||||||
Address | 4-57 Urafunecho, Minamiku, Yokohama | ||||||
TEL | 045-261-5656 | ||||||
Homepage URL | |||||||
takeru-a@umin.ac.jp |
Sponsor | |
Institute | Yokohama City University |
Institute | |
Department |
Funding Source | |
Organization | Self funding |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Advanced Critical Care and Emergency Center, Yokohama City University Medical Center |
Address | 4-57 Urafunecho, Minamiku, Yokohama City, Kanagawa |
Tel | 045-261-5656 |
takeru-a@umin.ac.jp |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Now collecting data. |
Management information | |||||||
Registered date |
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Last modified on |
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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=R000038808 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |