UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044393 |
|---|---|
| Receipt number | R000050711 |
| Scientific Title | Effect of Propofol in Pediatric Patients with Egg and Soybean Allergy |
| Date of disclosure of the study information | 2021/06/05 |
| Last modified on | 2023/06/02 15:36:50 |
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Basic information
Public title
Effect of Propofol in Pediatric Patients with Egg and Soybean Allergy
Acronym
Effect of Propofol in Pediatric Patients with Egg and Soybean Allergy
Scientific Title
Effect of Propofol in Pediatric Patients with Egg and Soybean Allergy
Scientific Title:Acronym
Effect of Propofol in Pediatric Patients with Egg and Soybean Allergy
Region
| Japan |
Condition
Condition
Egg and Soybean Allergy
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The basophil activation test (BAT) has been the focus of recent research as a safe method to identify the causative agent of anaphylaxis. It is known that when immediate allergy occurs, basophils in the blood are activated, and surface antigens such as CD203c and CD63 appear. Using this reaction, the patient's blood is mixed with the suspect drug in a test tube and the percentage of activated basophils in the total basophils is measured by a flow cytometer.
There is little literature on the safety of propofol in pediatric patients with food allergies (egg, soy), and its administration is not recommended in the guidelines.
The BAT test may be able to evaluate allergic reactions in the blood without actually administering propofol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
percentage of activated basophils
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 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children who are clinically allergic to eggs or soybeans, have been diagnosed as having food allergies, and will undergo surgery at our hospital, and the same number of children who are not allergic to eggs or soybeans and will undergo surgery at our hospital.
2. Children who have received a full explanation of the purpose of the study in the consent explanation document approved by the Ethical Review Committee, and whose families have given their free written consent (because the subject is a minor).
3. Patients who are able to have blood drawn at the time of the study
Translated with www.DeepL.com/Translator (free version)
Key exclusion criteria
Those who believe that even a blood sample of 1ml will have a negative impact on their health condition.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | kaneyuki |
| Middle name | |
| Last name | kawamae |
Organization
Yamagata University Medical School Hospital
Division name
Anesthesiology
Zip code
990-2331
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
023-633-1122
anesth-ym.jp-1974@mws.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | shun |
| Middle name | |
| Last name | nagashima |
Organization
Yamagata University Medical School Hospital
Division name
Department of Anesthesia
Zip code
990-2331
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
TEL
023-633-1122
Homepage URL
anesth-ym.jp-1974@mws.id.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Yamagata University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Support Division, Administrative Department, Yamagata University, Iida Campus
Address
2-2-2 Iida-Nishi, Yamagata City, Yamagata Prefecture
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-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 | 06 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study:The following subject background information will be collected from the medical record. 1 ml of blood will be drawn at the time of securing the venous route during induction of anesthesia, and BAT test will be performed with the obtained blood.Subject background:Gender, age, medical history, allergy history, medication.Collection of subjects:Allergic children who have given their consent for blood collection before surgery will be included in the study, and the study will be conducted until the specified number of patients is reached.Non-allergic children will be assigned in a manner that does not differ significantly from the gender and age structure of the allergic population, and those who have given consent will be included in the study until the specified number of subjects is reached.
Management information
Registered date
| 2021 | Year | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050711
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
