UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026557
Receipt No. R000030494
Scientific Title Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by leukocyte analysis and coagulation analysis
Date of disclosure of the study information 2017/04/01
Last modified on 2017/04/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by leukocyte analysis and coagulation analysis
Acronym Development of diagnostic methods in anaphylaxis
Scientific Title Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by leukocyte analysis and coagulation analysis
Scientific Title:Acronym Development of diagnostic methods in anaphylaxis
Region
Japan

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

Objectives
Narrative objectives1 Elucidation of pathogenic mechanism and development of diagnostic methods in anaphylaxis by in vitro analysis
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of surface marker in leukocytes between pre-and post-allergic reaction
Key secondary outcomes Changes of thromboelastogram between pre-and post-allergic reaction

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
0 years-old <=
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria The patients who were diagnosed as having or suspected of having an immediate hypersensitivity reaction (Grade 2 or 3) in perioperative period

Healthy control 20 years of age or older
Key exclusion criteria The patients who did not consent to this study
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuki Sugiyama
Organization Shinshu University Hospital
Division name Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto, Japan
TEL 0263-37-2670
Email ysugiyama@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Sugiyama
Organization Shinshu University Hospital
Division name Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto, Japan
TEL 0263-37-2670
Homepage URL
Email ysugiyama@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 01 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
2017 Year 03 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Clinical data at anaphylaxis
(Demographic data, laboratory findings and clinical courses)

Management information
Registered date
2017 Year 03 Month 14 Day
Last modified on
2017 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030494

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.