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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026400
Receipt No. R000030163
Scientific Title Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Date of disclosure of the study information 2017/03/06
Last modified on 2017/03/05

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Basic information
Public title Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Acronym Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Scientific Title Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Scientific Title:Acronym Measurement of specific IgE antibody levels to identify the causative agent of anaphylaxis
Region
Japan

Condition
Condition perioperative anaphylaxis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We are performing specific IgE antibody measurement in the patient with perioperative anaphylaxis and considering its diagnostic accuracy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic accuracy of specific IgE antibody measurement in the patient with anaphylaxis
Key secondary outcomes

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
0 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria 1)The patient with a history of perioperative anaphylaxis
2)The patient whose causative agent of anaphylaxis has been determined by "The study for determining the drug responsible for perioperative anaphylaxis by using skin test and flow cytometry"
3)The patient provided a written consent to participate in this study
Key exclusion criteria 1)The patient doctor judged inappropriate to participate in this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Takazawa
Organization Gunma University Hospital
Division name Intensive Care Unit
Zip code
Address 3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL 027-220-8693
Email takazawt@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Saito
Organization Gunma University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL 027-220-8454
Homepage URL
Email shigerus@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 06 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
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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measurement of specific IgE antibody levels

Management information
Registered date
2017 Year 03 Month 05 Day
Last modified on
2017 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030163

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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