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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005117
Receipt No. R000006082
Scientific Title The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children
Date of disclosure of the study information 2011/02/21
Last modified on 2018/12/27

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Basic information
Public title The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children
Acronym The efficacy of recombinant thrombomodulin for post transplant children
Scientific Title The efficacy of recombinant thrombomodulin for post transplant coagulopathy in children
Scientific Title:Acronym 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
1st name
Middle name
Last name Reo Tanoshima
Organization Yokohama City University Hospital
Division name Department of Pediatrics
Zip code
Address 3-9 Fukuura kanazawaku Yokohama Kanagawa
TEL 045-787-2800
Email

Public contact
Name of contact person
1st name
Middle name
Last name Reo Tanoshima
Organization Yokohama City University Hospital
Division name Department of Pediatrics
Zip code
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)

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 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

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2010 Year 10 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000006082

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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