UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022640 |
|---|---|
| Receipt number | R000025850 |
| Scientific Title | Retrospective analysis of safety and effectiveness of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation in children. |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2018/12/27 01:13:23 |
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Basic information
Public title
Retrospective analysis of safety and effectiveness of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation in children.
Acronym
Retrospective analysis of safety and effectiveness of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation in children.
Scientific Title
Retrospective analysis of safety and effectiveness of recombinant thrombomodulin for vascular endothelial syndrome after hematopoietic cell transplantation in children.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Reo Tanoshima |
Organization
Yokohama City University
Division name
Department of Pediatrics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
81-45-787-2800
tanoshima-ykh@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reo Tanoshima |
Organization
Yokohama City University
Division name
Department of Pediatrics
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
81-45-787-2800
Homepage URL
tanoshima-ykh@umin.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025850
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
