UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054113 |
|---|---|
| Receipt number | R000061208 |
| Scientific Title | Retrospective investigative analysis in effectiveness and adverse effects of HLA-matched platelet concentrates |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/10/14 15:52:47 |
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Basic information
Public title
Retrospective investigative analysis in effectiveness and adverse effects of HLA-matched platelet concentrates
Acronym
Retrospective observation of HLA-matched platelet concentrates
Scientific Title
Retrospective investigative analysis in effectiveness and adverse effects of HLA-matched platelet concentrates
Scientific Title:Acronym
Retrospective observation of HLA-matched platelet concentrates
Region
| Japan |
Condition
Condition
PC-HLA supplied from Japan red cross from 2000/1/1 to 2023/12/31.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy and safety of PC-HLA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy and safety of PC-HLA
Key secondary outcomes
Factors affected to the efficacy of PC-HLA and suitability coincidence with guideline
Base
Study type
Others,meta-analysis etc
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
patients who HLA matched platelet concentrates were transfused.
Key exclusion criteria
nothing
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akaru |
| Middle name | |
| Last name | Ishida |
Organization
International medical center, Saitama medical university
Division name
Division of transfusion and cell transplantation
Zip code
350-1298
Address
1397-1, Yamane, Hidaka city, Saitama prefecture
TEL
0429844111
aishida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Akaru |
| Middle name | |
| Last name | Ishida |
Organization
International medical center, Saitama medical university
Division name
Division of transfusion and cell transplantation
Zip code
350-1298
Address
1397-1, Yamane, Hidaka city, Saitama prefecture
TEL
+81367656888
Homepage URL
aishida@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
Akaru Ishida
Funding Source
Organization
Japanese Association of Transfusion and Cell Therapy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International medical center, Saitama medical university
Address
1397-1, Yamane, Hidaka city, Saitama prefecture
Tel
+81-429844111
imc_irb@saitama-med.ac.jp
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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Nothing
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061208
