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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044393
Receipt No. 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 2021/06/01

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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
Email 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
Email anesth-ym.jp-1974@mws.id.yamagata-u.ac.jp

Sponsor
Institute Yamagata University Medical School Hospital
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 13 Day
Date of IRB
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
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050711

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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