UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035350 |
|---|---|
| Receipt number | R000040126 |
| Scientific Title | Japanese Epidemiologic Study for Perioperative Anaphylaxis |
| Date of disclosure of the study information | 2018/12/25 |
| Last modified on | 2019/02/01 15:33:37 |
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Basic information
Public title
Japanese Epidemiologic Study for Perioperative Anaphylaxis
Acronym
Japanese Epidemiologic Study for Perioperative Anaphylaxis (JESPA)
Scientific Title
Japanese Epidemiologic Study for Perioperative Anaphylaxis
Scientific Title:Acronym
Japanese Epidemiologic Study for Perioperative Anaphylaxis (JESPA)
Region
| Japan |
Condition
Condition
anaphylaxis
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are going to perform skin tests and basophil activation tests to identify culprit drug(s) in patients with perioperative anaphylaxis. Further, we will analyze data of incidence and severity of anaphylaxis so that we can provide information to develop perioperative anaphylaxis guideline that will be issued by Japanese Society of Anesthesiologists. We will build a system that can deal with anaphylaxis occurred nationwide.
Basic objectives2
Others
Basic objectives -Others
Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of causative drug(s) of perioperative anaphylaxis
Key secondary outcomes
Incidence and severity of perioperative anaphylaxis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patient whose consent has been obtained in writing with respect to participation in this study
2) The patient showing Grade 2 or severer anaphylactic reactions during perioperative period. In the medical institutions conducting research A only, the subject will be patient showing Grade 3 or severer anaphylactic reactions
Key exclusion criteria
1) The patient who did not give consent for participation
2) The patient who use or have a plan to use unapproved drugs such as investigational drugs
3) The patient to whom a doctor judged inappropriate for participating in this study
Target sample size
150
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
TEL
027-220-8698
takazawt@gunma-u.ac.jp
Public contact
Name of contact person
| 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
TEL
027-220-8698
Homepage URL
takazawt@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Anesthesiologists
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
| 2018 | Year | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 23 | Day |
Last modified on
| 2019 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040126
