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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002656
Receipt No. R000003225
Scientific Title The study for prophylaxis of tetanus for taruma patients admitted in emergency room
Date of disclosure of the study information 2009/10/22
Last modified on 2011/07/27

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Basic information
Public title The study for prophylaxis of tetanus for taruma patients admitted in emergency room
Acronym Prophylaxis of tetanus
Scientific Title The study for prophylaxis of tetanus for taruma patients admitted in emergency room
Scientific Title:Acronym Prophylaxis of tetanus
Region
Japan

Condition
Condition trauma patients
Classification by specialty
Surgery in general Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to validate the efficiency of the TQS(Tetanus Quick Stick) for tetanus antibody and establish a system based on epidemiological survey of tetaus prophylaxis in emergency room.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome is to compare the sensitivity and the specificity of TQS(Tetanus Quick Stick) for the tetanus antibody with them of ELISA(Enzyme-Linked ImmunoSorbent Assay) method.
Key secondary outcomes The secondry outcome is survey patients with tetanus antibody epidemiology.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ALL trauma pacients admitted in the emergency room
Key exclusion criteria Foreigners
Not agreement of this study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryo Sasaki
Organization National Center for Global Health and Medicine
Division name Department of Emergency Medicine
Zip code
Address 1-21-1,Toyama,Shinjyuku-ku,Tokyo,Japan
TEL 03-3202-7181(5292)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Sasaki
Organization National Center for Global Health and Medicine
Division name Department of Emergency Medicine
Zip code
Address 1-21-1,Toyama,Shinjyuku-ku,Tokyo,Japan
TEL 03-3202-7181
Homepage URL
Email ryonz@mug.biglobe.ne.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization Bureau of International Cooperation
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 国立国際医療研究センター病院
(National Center for Global Health and Medicine)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
<Demographic Data>
all subjects; 253
average age; 48.6 (5-96)
male:female; 185:68
the tetanus antibody titer was 0.1 IU/mL or more; 153/253 (60.5%)

Result 1: The accuracy of TQS
          (compared with ELISA)
69.3% sensitivity, 96.0% specificity, and 96.4% positive predictive value

Result 2: Difference in the prevalence of tetanus antibody due to age

born in 1967 or before  52/139 (37.4%)
(included unknown)
born in 1968 or after   101/114 (88.6%)

*1968 when tetanus toxoid was introduced into routine immunization in Japan.
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
2009 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information The subject is trauma pacients with agreement of this study admitted in our emergency room. The material and methods are 1) to measure the tetanus antibodies on TQS(Tetanus Quick Stick) and ELISA method from the blood sample of the patients, 2) and examine the occurance of tetanus about two weeks after the injury.

Management information
Registered date
2009 Year 10 Month 22 Day
Last modified on
2011 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003225

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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