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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021505
Receipt No. R000024787
Scientific Title The study for determining the drug resposible for perioperative anaphylaxis by using skin test and flow cytometry
Date of disclosure of the study information 2016/03/25
Last modified on 2018/12/21

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Basic information
Public title The study for determining the drug resposible for perioperative anaphylaxis by using skin test and flow cytometry
Acronym The study for determining the drug resposible for perioperative anaphylaxis
Scientific Title The study for determining the drug resposible for perioperative anaphylaxis by using skin test and flow cytometry
Scientific Title:Acronym The study for determining the drug resposible for perioperative anaphylaxis
Region
Japan

Condition
Condition Perioperative anaphylaxis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identifying the drug responsible for perioperative anaphylaxis is important for preventing the recurrence of anaphylaxis. We are going to perform skin tests and flow cytometry in this study
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identifying the drug responsible for perioperative anaphylaxis
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 Maneuver
Interventions/Control_1 Skin test and flow cytometry will be performed once per subject.
Drugs using for these tests will be different depending on cases.
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The patient 15 years or older, who underwent general or spinal anesthesia or their next of kin
2) The patient with perioperative anaphylaxis
3) The patient whose consent has been obtained in writing with respect to participation in this study
Key exclusion criteria 1)The pregnant woman /The patient who has a possibility of pregnancy
2)The patient taking beta blocker
3)The patient taking steroid
4)The patient to whom a doctor judged inappropriate for participating in this study
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nagahide Yoshida
Organization Saiseikai Maebshi Hospital
Division name Department of Anesthesiology
Zip code
Address 564-1 Kamisinden-machi, Maebashi, Gunma
TEL 027-252-6011
Email totemkopf@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Seki
Organization Saiseikai Maebshi Hospital
Division name Crinical Reserch Center
Zip code
Address 564-1 Kamisinden-machi, Maebashi, Gunma
TEL 027-252-6011
Homepage URL
Email totemkopf@hotmail.co.jp

Sponsor
Institute Saiseikai Maebshi Hospital
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
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
2016 Year 03 Month 25 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 Completed
Date of protocol fixation
2016 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 29 Day
Last follow-up date
2017 Year 12 Month 10 Day
Date of closure to data entry
2017 Year 12 Month 10 Day
Date trial data considered complete
2017 Year 12 Month 10 Day
Date analysis concluded
2018 Year 02 Month 26 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 17 Day
Last modified on
2018 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024787

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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