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

Email

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


Email

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


Email



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