UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002656 |
|---|---|
| Receipt number | 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 02:01:41 |
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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)
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
ryonz@mug.biglobe.ne.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003225
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
