UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007268 |
|---|---|
| Receipt number | R000008574 |
| Scientific Title | Prophylaxis of Tetanus by Quick Test study |
| Date of disclosure of the study information | 2012/02/14 |
| Last modified on | 2014/05/09 16:15:06 |
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Basic information
Public title
Prophylaxis of Tetanus by Quick Test study
Acronym
Proteqt study
Scientific Title
Prophylaxis of Tetanus by Quick Test study
Scientific Title:Acronym
Proteqt study
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 efficacy of the Tetanus Quick Stick (TQS) for tetanus antibody and establish a system based on epidemiological survey of tetanus prophylaxis.
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 Tetanus Quick Stick (TQS) for tetanus antibody with them of Particle Agglutination 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
| 90 | months-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Trauma pacients admitted in the emergency room while the laboratory is available.
The sample is used by drawing blood to other purpose.
Key exclusion criteria
Not agreement of this study
Target sample size
2200
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 and Critical care
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo, Japan
TEL
03-3202-7181
rysasaki@hosp.ncgm.go.jp
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 and Critical care
Zip code
Address
1-21-1, Toyama, Shinjyuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
rysasaki@hosp.ncgm.go.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
独立行政法人国立国際医療研究センター(東京都)
新潟市民病院（新潟県）
独立行政法人国立病院機構水戸医療センター（茨城県）
兵庫県立淡路病院（兵庫県）
順天堂大学医学部付属浦安病院（千葉県）
福山市民病院（広島県）
長崎大学病院（長崎県）
島根大学医学部付属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
http://www.jast-hp.org/syourai/hasyofu.html
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
The subject is trauma pacients admitted in emergency room while the laboratory is available.
The sample is used by drawing blood to other purpose.
The meterial and methods are 1) to measure the tetanus antibodies on Tetanus Quick Stick (TQS) and Particle Agglutination method from the sample of the pacients, 2) and examine the occurance of tetanus about 21 days after the injury.
Management information
Registered date
| 2012 | Year | 02 | Month | 11 | Day |
Last modified on
| 2014 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008574
| 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 |
