UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective analysis of safety and effectiveness of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation in children.
Title of the study (Brief title)	Retrospective analysis of safety and effectiveness of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation in children.
Region	Japan

Condition
Condition	Pediatric patients who developed vascular endothelial syndrome after hematopoietc cell transplantation.
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and effectivenesss of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the duration until improvement of vascular endothelial syndrome between the patients with rTM and without rTM.
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	0 years-old <=
Age-upper limit	18 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who developed vascular endothelial syndrome after hematopoietic cell transplantation.
Key exclusion criteria	Patients who did not meet the inclusion criteria. Patients who disagreed to write the consent.
Target sample size	30

Research contact person
Name of lead principal investigator	Reo Tanoshima
Organization	Yokohama City University
Division name	Department of Pediatrics
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	81-45-787-2800
Email	tanoshima-ykh@umin.ac.jp

Public contact
Name of contact person	Reo Tanoshima
Organization	Yokohama City University
Division name	Department of Pediatrics
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	81-45-787-2800
Homepage URL
Email	tanoshima-ykh@umin.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
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	横浜市立大学附属病院（神奈川県） 神奈川県立こども医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 05 Month 12 Day
Anticipated trial start date	2016 Year 05 Month 12 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	Information of the patients who were performed stem cell transplantation will be analyzed retrospectively.

Management information
Registered date	2016 Year 06 Month 07 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025850