UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children
Title of the study (Brief title)	The efficacy of recombinant thrombomodulin for post transplant children
Region	Japan

Condition
Condition	children with coagulopathy after hematopoietic stem cell transplantation
Classification by specialty	Pediatrics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of recombinant thrombomodulin for children with coagulopathy after hematopoietic stem cell transplantation
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the safety of recombinant thrombomodulin for children with coagulopathy after hematopoietic stem cell transplantation
Key secondary outcomes	To evaluate the rate to develop microangiopathy after hematopoietic stem cell transplantation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Eligible Patients 1) Children who will be performed hematopoietic stem cell transplantation (HSCT) in this hospital. 2) D-dimer level above 1.0 ug/ml at 5 through 28 days after HSCT. 3) Written informed consent will be obtained from patients or parents. Schedule of administration 1) 380U/kg div per day continued until the normalization of D-dimer value. 2) Blood sample tested at least 3 times per week. The administration should be stopped when active bleeding occurs or laboratory data finds tendency of bleeding. Evaluation Evaluation of adverse events will be performed until 28 days after the administration. CTCAE 3.0 will be used to evaluate adverse events. This study will be closed when 50 patients are eligible in 5 years. Grade 4 adverse events may bring forward the end of the study.
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	20 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Children who will be performed hematopoietic stem cell transplantation (HSCT) in this hospital. 2) D-dimer level above 1.0 ug/ml at 5 through 28 days after HSCT. 3) Written informed consent will be obtained from patients or parents.
Key exclusion criteria	1) The Patients with bleeding in brain, lung, or intestine. 2) Past history of allergy for recombinant thrombomodulin 3) Patients who refused to participate in the study 4) Other reasons by which physicians decide not to be eligible for the study.
Target sample size	50

Research contact person
Name of lead principal investigator	Reo Tanoshima
Organization	Yokohama City University Hospital
Division name	Department of Pediatrics
Address	3-9 Fukuura kanazawaku Yokohama Kanagawa
TEL	045-787-2800
Email

Public contact
Name of contact person	Reo Tanoshima
Organization	Yokohama City University Hospital
Division name	Department of Pediatrics
Address	3-9 Fukuura kanazawaku Yokohama Kanagawa
TEL	045-787-2800
Homepage URL
Email	tanotch@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University Hospital
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

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 10 Month 01 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2016 Year 10 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 01 Day
Date trial data considered complete	2017 Year 03 Month 01 Day
Date analysis concluded	2021 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 02 Month 21 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=R000006082