UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the change of coagulation in pediatric patients with steroid pulse therapy and systemic steroid administration
Title of the study (Brief title)	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	Chiai Nagae
Organization	St. Marianna University School of Medicine
Division name	Department of pediatrics
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	Yotaro Umezawa
Organization	St. Marianna University School of Medicine
Division name	Department of pediatrics
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 12 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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