UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035350
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email takazawt@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040126

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.