UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016761 |
|---|---|
| Receipt number | R000019269 |
| Scientific Title | Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study |
| Date of disclosure of the study information | 2015/03/10 |
| Last modified on | 2017/03/14 08:55:17 |
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Basic information
Public title
Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study
Acronym
Skin test and flow cytometry in healthy volunteers
Scientific Title
Skin test and flow cytometry in healthy volunteers to establish the method for determining causative drug of perioperative anaphylaxis: A preliminary study
Scientific Title:Acronym
Skin test and flow cytometry in healthy volunteers
Region
| Japan |
Condition
Condition
Anaphylaxis
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although skin test has been widely used for identifying causative drug of anaphylaxis, it has some disadvantages including a risk of recurrent anaphylaxis and pain. The purpose this study is to establish an ideal tool for determing causative drug of perioperative anaphylaxis. For this purpose, we will focus on basophil activate test (BAT) with flow cytometry as an alternative to skin test. We will seek the maximum concentration not to see pseudo-positive reaction in healthy volunteers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Seeking the optimum concentration of drugs for skin test and BAT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Histamin as a positive control
Normal saline as a negative control
Suspected drugs including sugamamdex and cephazolin
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A volunteer who is 20 years or older
2) Avolunteer whose written consent has been obtained regarding participation in this study
Key exclusion criteria
1)A pregnant woman /A patient who has a possibility of pregnancy
2)A volunteer taking beta blocker
3)A volunteer taking steroid
4)A volunteer with past history of perioperative anaphylaxis
5)A volunteer to whom a doctor judged inappropriate for participating in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru SAITO |
Organization
Gunma University Hospital
Division name
Department of Anesthesiology
Zip code
Address
3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL
027-220-8454
shigerus@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori TAKAZAWA |
Organization
Gunma University Hospital
Division name
Department of Anesthiology
Zip code
Address
3-39-15 Showa-machi, Maebashi , Gunma, Japan 371-8511
TEL
027-220-8454
Homepage URL
takazawt@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 10 | 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
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To estimate the optimum concentration of the perioperative agent for a skin test and BAT
Management information
Registered date
| 2015 | Year | 03 | Month | 10 | Day |
Last modified on
| 2017 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019269
