UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045975 |
|---|---|
| Receipt number | R000052473 |
| Scientific Title | Association of Tryptase and Histamine with anaphylaxis severity during anesthesia |
| Date of disclosure of the study information | 2021/11/03 |
| Last modified on | 2023/12/16 11:11:49 |
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Basic information
Public title
Association of Tryptase and Histamine with anaphylaxis severity during anesthesia
Acronym
Association of Tryptase and Histamine with anaphylaxis severity during anesthesia
Scientific Title
Association of Tryptase and Histamine with anaphylaxis severity during anesthesia
Scientific Title:Acronym
Association of Tryptase and Histamine with anaphylaxis severity during anesthesia
Region
| Japan |
Condition
Condition
anaphylaxis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the relationship between anaphylaxis severity and blood tryptase and histamine levels.
Basic objectives2
Others
Basic objectives -Others
To study the relationship between anaphylaxis severity and blood tryptase and histamine levels.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
none
Key secondary outcomes
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
| 1 | months-old | <= |
Age-upper limit
| 92 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients with suspected anaphylaxis based on clinical findings during anesthesia
Key exclusion criteria
none
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Yumiko |
| Middle name | |
| Last name | Nishio |
Organization
Kurume University School of Medicine
Division name
Department of Anesthesiology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942317578
nishio_yumiko@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Nishio |
Organization
Kurume University School of Medicine
Division name
Department of Anesthesiology
Zip code
830-0011
Address
67 Asahi-machi, Kurume, Fukuoka
TEL
0942317578
Homepage URL
nishio_yumiko@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
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
Kurume University School of Medicine
Address
67 Asahi-machi, Kurume, Fukuoka
Tel
0942317578
nishio_yumiko@kurume-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 | 11 | Month | 03 | 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
25
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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Medical information (sex, height and weight, medical history, medical history, blood data: blood tryptase level and blood histamine level) obtained during normal medical treatment will be used for comparison. In anaphylaxis, we will compare how much the blood tryptase level and blood histamine level are elevated compared to the reference values, and how these values change in severe cases of anaphylaxis.
This study will be conducted only at our own institution, no samples or information will be provided to other institutions.
Management information
Registered date
| 2021 | Year | 11 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052473
