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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041275
Receipt No. 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 2020/08/01

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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 National Hospital Organization Mito Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code 311-3193
Address 280 Sakuranosato, Ibarakimachi, Higashi-ibarakigun, Ibaraki, 3113193, Japan
TEL 029-240-7711
Email asuka-t@umin.ac.jp

Public contact
Name of contact person
1st name Asuka
Middle name
Last name Tsuchiya
Organization National Hospital Organization Mito Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code 311-3193
Address 280 Sakuranosato, Ibarakimachi, Higashi-ibarakigun, Ibaraki, 3113193, Japan
TEL 029-240-7711
Homepage URL
Email asuka-t@umin.ac.jp

Sponsor
Institute National Hospital Organization Mito Medical Center
Institute
Department

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 National Hospital Organization Mito Medical Center IRB
Address 280 Sakuranosato, Ibarakimachi, Higashi-ibarakigun, Ibaraki, 3113193, Japan
Tel 029-240-7711
Email 200-mitokenkyukanri@mail.hosp.go.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
2020 Year 08 Month 01 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 Preinitiation
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 07 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
2020 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.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


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