UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022365 |
|---|---|
| Receipt number | R000023952 |
| Scientific Title | The survey of perioperative anaphylaxis in Gunma University Hospital and neighbor hospitals |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2024/11/24 09:59:32 |
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Basic information
Public title
The survey of perioperative anaphylaxis in Gunma University Hospital and neighbor hospitals
Acronym
The survey of perioperative anaphylaxis
Scientific Title
The survey of perioperative anaphylaxis in Gunma University Hospital and neighbor hospitals
Scientific Title:Acronym
The survey of perioperative anaphylaxis
Region
| Japan |
Condition
Condition
Perioperative anaphylaxis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey the occurrences of drug-induced perioperative anaphylaxis in Gunma University Hospital and neighbor hospitals
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To calculate the incidence rate of each drug-induced perioperative anaphylaxis
Key secondary outcomes
To analyze the risk factor of anaphylaxis during anesthesia
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
| Not applicable |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who received anesthesia in the participating hospitals between January 1st, 2009 and December 31st, 2018
Key exclusion criteria
Patients who refused to participate to the study
Target sample size
180000
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
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
0272208454
takazawt@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Takazawa |
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
027-220-7111
Homepage URL
takazawt@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
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
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
Tel
027-220-7111
hitotaisho-ciru@ml.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
伊勢崎市民病院（群馬県）、群馬県済生会前橋病院（群馬県）、足利赤十字病院（栃木県）、群馬中央病院（群馬県）、高崎総合医療センター（群馬県）、群馬県立心臓血管センター（群馬県）、群馬県立がんセンター（群馬県）、埼玉県立がんセンター（埼玉県）、桐生厚生総合病院（群馬県）、日高病院（群馬県）、高瀬クリニック（群馬県）、深谷赤十字病院（埼玉県）、渋川医療センター（群馬県）、利根中央病院（群馬県）、荻窪病院（東京都）、関東労災病院（神奈川県）、栃木県済生会宇都宮病院（栃木県）、自治医科大学（栃木県）、佐久医療センター（長野県）、四谷メディカルキューブ（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 25 | 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
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will survey the incidence of anaphylaxis and the total amount of each agents used in operation room of participating hospitals
Management information
Registered date
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023952
