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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007268
Receipt No. 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

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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
Email 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
Email rysasaki@hosp.ncgm.go.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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008574

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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