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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035173
Receipt No. 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

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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
Email 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
Email y2umezawa@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040084

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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