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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000019588 |
Receipt No. | R000022645 |
Scientific Title | A multicenter, prospective observational study for the epidemiology of severe trauma |
Date of disclosure of the study information | 2015/11/15 |
Last modified on | 2018/05/17 |
Basic information | ||
Public title | A multicenter, prospective observational study for the epidemiology of severe trauma | |
Acronym | Epidemiology of severe trauma | |
Scientific Title | A multicenter, prospective observational study for the epidemiology of severe trauma | |
Scientific Title:Acronym | Epidemiology of severe 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 | To assess epidemiology and pathophysiology of trauma.
To establish diagnostic and therapeutic methods for trauma. |
Basic objectives2 | Others |
Basic objectives -Others | Observational study for predicting trauma outcome and evaluating intervention for trauma. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 28-day mortality |
Key secondary outcomes | ICU free days
Ventilator free days 24-hour amount of blood transfusion Subsequent Acute Respiratory Distress Syndrome (ARDS) |
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 | Injury Severity Score >15 | |||
Key exclusion criteria | Out of hospital cardiac arrest | |||
Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokkaido University Graduate School of Medicine | ||||||
Division name | Acute and Critical Care Medicine | ||||||
Zip code | |||||||
Address | N15W7, Kita-ku, Sapporo | ||||||
TEL | +81-11-706-7377 | ||||||
gando@med.hokudai.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Japanese Association for Acute Medicine | ||||||
Division name | Secretariat | ||||||
Zip code | |||||||
Address | 3-3-12, Hongo, Bunkyo-ku, Tokyo | ||||||
TEL | +81-3-5840-9870 | ||||||
Homepage URL | http://www.jaam.jp/html/jaamforecast/index.html | ||||||
editorial-jaam@umin.net |
Sponsor | |
Institute | Japanese Association for Acute Medicine |
Institute | |
Department |
Funding Source | |
Organization | Japanese Association for Acute Medicine |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://www.jaam.jp/html/jaamforecast/index.html |
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 | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | A prospective and multi-centered case-control study of severely injured (Injury Severity Score >15) trauma patients. Planned sample size is 500 subjects to enroll from January 1, 20016 for a year. This study gathers information for baseline characteristics, trauma severity, laboratory tests, undergoing interventions and outcomes of trauma subjects. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022645 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |