UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036981 |
|---|---|
| Receipt number | R000042130 |
| Scientific Title | Long term outcome of B-HYPO study |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2019/06/06 11:10:27 |
* 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
Long term outcome of B-HYPO study
Acronym
Long term outcome of B-HYPO study
Scientific Title
Long term outcome of B-HYPO study
Scientific Title:Acronym
Long term outcome of B-HYPO study
Region
| Japan |
Condition
Condition
Traumatic brain injury
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the association between TTM and long term outcome
Basic objectives2
Others
Basic objectives -Others
To examine the association between TTM and long term outcome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glasgow Outcome Scale
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
TBI
Key exclusion criteria
Informed consent was not available
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Hifumi |
Organization
St. Like's International Hospital
Division name
Emergency and Critical Care Medicine
Zip code
104-8560
Address
9-1, Akashichou, Chuouku, 104-8560, Tokyo, Japan
TEL
03-3541-5151
hifumitoru@gmail.com
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Hifumi |
Organization
St. Like's International Hospital
Division name
Emergency and Critical Care Medicine
Zip code
104-8560
Address
9-1, Akashichou, Chuouku, 104-8560, Tokyo, Japan
TEL
03-3541-5151
Homepage URL
hifumitoru@gmail.com
Sponsor or person
Institute
St. Like's International Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Like's International Hospital
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
St. Like's International Hospital
Address
9-1, Akashichou, Chuouku, 104-8560, Tokyo, Japan
Tel
03-3541-5151
hifumitoru@gmail.com
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
| 2019 | Year | 10 | 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
| 2019 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
SES
Management information
Registered date
| 2019 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042130
