UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041275 |
|---|---|
| Receipt number | R000047049 |
| Scientific Title | Multicenter collaborative research on natural history, quality of life, social reintegration of moderate to severe trauma patients after hospital survival discharge |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2023/08/07 15:41:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
FOLLOW-UP Trauma: Functional Outcomes, quality of Life, and Long-term patient OWn histories after Trauma survival
Acronym
FOLLOW-UP Trauma
Scientific Title
Multicenter collaborative research on natural history, quality of life, social reintegration of moderate to severe trauma patients after hospital survival discharge
Scientific Title:Acronym
Multicenter collaborative research on natural history, quality of life, social reintegration of moderate to severe trauma patients after hospital survival discharge
Region
| Japan |
Condition
Condition
Trauma
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the project is to make a comprehensive long-term trauma outcome database, describe patients' long-term outcomes in the first two years after the injury, and explore the association between social patient background and long-term outcomes.
Basic objectives2
Others
Basic objectives -Others
To achieve project purposes, the study will use quantitative and qualitative methods as follows:
1. construct a long-term registry which pre-hospital to in-hospital to after-hospital, connecting the already-existing database and new data.
2. describe the HRQL, trajectory, healthcare use, and social reintegration of seriously injured people in the first two years.
3. asses the degree of change in HRQL and social connection between pre-injury and post-injury.
4. explore the association between comprehensive long-term outcomes and social patient background or trauma care delivery, and establish the predictor of long-term trauma outcomes.
5. propose to society "tailor-made post-discharge medical care," optimized for each patient to help survivors regain control over their lives.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We will collect both qualitative and quantitative outcomes. Qualitative outcomes are as follows; health-related quality of life (EQ-5D-5L/SF-12v2), return to work related outcomes, and living place. Quantitative outcomes are including long-term mortality, frequency of visiting to outpatient department, and frequency of re-admission.
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 16 years or older
2. Direct transport from the scene of injury by ambulance or physician staffed helicopter or ambulance.
3. Transfer hospital within 24 hours from injury for advanced treatment purposes.
4. Injury Severity Score > 12 points.
Key exclusion criteria
1. Cardiopulmonary arrest on admission to emergency department.
2. Burn patients
3. When attending physician determines that participation in this study is inappropriate.
Target sample size
3600
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokai University School of Medicine.
Division name
Department of Emergency and Critical Care Medicine
Zip code
2591193
Address
143, Shimokasuya, Isehara-city, Kanagawa, 2591193, Japan
TEL
0463-93-1121
asuka-t@tsc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Tsuchiya |
Organization
Tokai University School of Medicine.
Division name
Department of Emergency and Critical Care Medicine
Zip code
2591193
Address
143, Shimokasuya, Isehara-city, Kanagawa, 2591193, Japan
TEL
0463-93-1121
Homepage URL
asuka-t@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutenal Review Board for Clinical Research, Tokai University
Address
143, Shimokasuya, Isehara-city, Kanagawa, 2591193, Japan
Tel
0463931121
tokai-rinsho@ml.tokai-u.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
東海大学医学部医学科総合診療学系救命救急医学講座
独立行政法人国立病院機構水戸医療センター
東北大学大学院医学系研究科外科病態学講座救急医学
国立国際医療研究センター
公立豊岡組合立但馬救命救急センター
日本医科大学千葉北総病院
埼玉医科大学総合医療センター高度救命救急センター
京都第二赤十字病院
亀田総合病院 救命救急センター
済生会横浜市東部病院 重症外傷センター
東京医科歯科大学医学部附属病院 救命救急センター
帝京大学医学部附属病院 高度救命救急センター
聖路加国際病院
北海道大学病院救急科
大阪市立大学医学部 救急医学
大阪大学医学部附属病院
佐賀大学医学部附属病院高度救命救急センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/ace/3/2/3_No.21-08/_pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
1000
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
To explore factors associated with social patient background and long-term prognostic outcomes
To explore factors associated with social patient background and short- and long-term prognostic outcomes during hospitalization and after hospital survival discharge
Management information
Registered date
| 2020 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047049
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
