UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044591 |
|---|---|
| Receipt number | R000050651 |
| Scientific Title | The study for identifying the antigen of culprit agents of perioperative anaphylaxis |
| Date of disclosure of the study information | 2021/06/18 |
| Last modified on | 2021/06/18 17:31:27 |
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Basic information
Public title
The study for identifying the antigen of culprit agents of perioperative anaphylaxis
Acronym
The study for identifying the antigen of culprit agents of perioperative anaphylaxis
Scientific Title
The study for identifying the antigen of culprit agents of perioperative anaphylaxis
Scientific Title:Acronym
The study for identifying the antigen of culprit agents of perioperative anaphylaxis
Region
| Japan |
Condition
Condition
Anaphylaxis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify the antigenic site of the causative agent in patients with anaphylaxis
Basic objectives2
Others
Basic objectives -Others
Diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basophil activation tests conducted 4 to 6 weeks after anaphylaxis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Blood sampling
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
Those who have had anaphylaxis during the perioperative period
Key exclusion criteria
Those who the doctor deems inappropriate for participating in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
Organization
Gunma University Hospital
Division name
Intensive Care Unit
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan 371-8511
TEL
027-220-8454
takazawt@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Nagumo |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan 371-8511
TEL
027-220-8454
Homepage URL
m1920023@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital, Department of Anesthesiology
Address
3-39-15 Showa-machi, Maebashi, Gunma, Japan 371-8511
Tel
027-220-8454
m1920023@gunma-u.ac.jp
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
| 2021 | Year | 06 | Month | 18 | 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
| 2021 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2036 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 18 | Day |
Last modified on
| 2021 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050651
| 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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