UMIN-CTR Clinical Trial

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
Email	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
Email	blaualounithe@gmail.com

Sponsor
Institute	Department of Emergency and Critical care Medicine, Juntendo University Urayasu Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045819