UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040184 |
|---|---|
| Receipt number | R000045819 |
| Scientific Title | Hypertonic saline for traumatic brain injury; a systematic review and meta-analysis |
| Date of disclosure of the study information | 2020/04/17 |
| Last modified on | 2020/04/17 12:31:42 |
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Basic information
Public title
Hypertonic saline for traumatic brain injury; a systematic review and meta-analysis
Acronym
Hypertonic saline for traumatic brain injury; a systematic review and meta-analysis
Scientific Title
Hypertonic saline for traumatic brain injury; a systematic review and meta-analysis
Scientific Title:Acronym
Hypertonic saline for traumatic brain injury; a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Traumatic brain injury
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of hypertonic saline on clinical outcomes in patients with traumatic brain injury by systematically reviewing the literature and synthesizing evidence of randomized controlled trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality
Key secondary outcomes
90-day and 180-day mortality, good neurological outcome rate, decline in ICP, and serum sodium level.
Base
Study type
Others,meta-analysis etc
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
Adult patients with traumatic brain injury.
Key exclusion criteria
Adolescents.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yukari |
| Middle name | |
| Last name | Miyoshi |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Emergency and Critical care Medicine
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
047-353-3111
blaualounithe@gmail.com
Public contact
Name of contact person
| 1st name | Yukari |
| Middle name | |
| Last name | Miyoshi |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Emergency and Critical care Medicine
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
047-353-3111
Homepage URL
blaualounithe@gmail.com
Sponsor or person
Institute
Department of Emergency and Critical care Medicine, Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
None/ 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
Department of Emergency and Critical care Medicine, Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
Tel
047-353-3111
blaualounithe@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
| 2020 | Year | 04 | Month | 17 | 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
125
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
| 2019 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Search method>
Electronic serach
1. the Cochrane Central Register of Controlled Trials(CENTRAL)
2. MEDLINE
3. Igaku Chuo Zasshi (ICHUSHI) Web
<Meta-analysis>
Meta-analysis will be performed using the Review Manger, Cochrane systematic review software, version 5.3.5 for Windows. We will use a random-effects model.
Management information
Registered date
| 2020 | Year | 04 | Month | 17 | Day |
Last modified on
| 2020 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045819
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
