UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021505 |
|---|---|
| Receipt number | 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 11:51:18 |
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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
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
totemkopf@hotmail.co.jp
Sponsor or person
Institute
Saiseikai Maebshi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024787
