UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035173 |
|---|---|
| Receipt number | R000040084 |
| Scientific Title | Study on the change of coagulation in pediatric patients with steroid pulse therapy and systemic steroid administration |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2018/12/07 19:08:21 |
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Basic information
Public title
Study on the change of coagulation in pediatric patients with steroid pulse therapy and systemic steroid administration
Acronym
Study on the change of coagulation in pediatric patients with steroid pulse therapy and systemic steroid administration
Scientific Title
Study on the change of coagulation in pediatric patients with steroid pulse therapy and systemic steroid administration
Scientific Title:Acronym
Study on the change of coagulation in pediatric patients with steroid pulse therapy and systemic steroid administration
Region
| Japan |
Condition
Condition
Disease undergoing steroid pulse therapy, the steroid systemic administration
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the change in coagulation at the time of administration of steroid by comparing the change of each coagulation factor before and after the steroid pulse therapy presumed high risk of thrombosis and systemic administration of steroid.
Basic objectives2
Others
Basic objectives -Others
If clothematological changes at the time of use of steroids in various disease states are clarified, it becomes possible to carry out prophylactic treatment of more appropriate thrombus in accordance with the disease state in future daily practice.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before and after administration of steroid, PT, APTT, Fibrinogen, D-dimer, as well as coagulation related factors and fibrinolysis related factors are measured.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pediatric patients with steroid pulse therapy or steroid systemic administration are included.
Key exclusion criteria
Abort when subjects and their families indicate intention to withdraw.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chiai Nagae |
Organization
St. Marianna University School of Medicine
Division name
Department of pediatrics
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL
044-977-8111
chiai-oi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yotaro Umezawa |
Organization
St. Marianna University School of Medicine
Division name
Department of pediatrics
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
y2umezawa@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 12 | Month | 07 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040084
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
