UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026400 |
|---|---|
| Receipt number | 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 | 2022/03/29 16:57:23 |
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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
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
shigerus@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 03 | Day |
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
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030163
