UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026557 |
|---|---|
| Receipt number | R000030494 |
| Scientific Title | Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by leukocyte analysis and coagulation analysis |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2023/05/19 12:00:16 |
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Basic information
Public title
Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by leukocyte analysis and coagulation analysis
Acronym
Development of diagnostic methods in anaphylaxis
Scientific Title
Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by leukocyte analysis and coagulation analysis
Scientific Title:Acronym
Development of diagnostic methods in anaphylaxis
Region
| Japan |
Condition
Condition
perioperative anaphylaxis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by in vitro analysis
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of surface marker in leukocytes between pre-and post-allergic reaction
Key secondary outcomes
Changes of thromboelastogram between pre-and post-allergic reaction
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who were diagnosed as having or suspected of having an immediate hypersensitivity reaction (Grade 2 or 3) in perioperative period
Healthy control 20 years of age or older
Key exclusion criteria
The patients who did not consent to this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Sugiyama |
Organization
Shinshu University Hospital
Division name
Anesthesiology and Resuscitology
Zip code
Address
3-1-1, Asahi, Matsumoto, Japan
TEL
0263-37-2670
ysugiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Sugiyama |
Organization
Shinshu University Hospital
Division name
Anesthesiology and Resuscitology
Zip code
Address
3-1-1, Asahi, Matsumoto, Japan
TEL
0263-37-2670
Homepage URL
ysugiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu 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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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 | 03 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data at anaphylaxis
(Demographic data, laboratory findings and clinical courses)
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030494
| 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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| Registered date | File name |
