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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002610
Receipt No. R000003184
Scientific Title The prevention of transfusion reactions by washed platelet concentrates in pediatric patients
Date of disclosure of the study information 2009/10/15
Last modified on 2014/01/21

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Basic information
Public title The prevention of transfusion reactions by washed platelet concentrates in pediatric patients
Acronym Washed platelet concentrates in pediatric patients
Scientific Title The prevention of transfusion reactions by washed platelet concentrates in pediatric patients
Scientific Title:Acronym Washed platelet concentrates in pediatric patients
Region
Japan

Condition
Condition Acute leukemia
Classification by specialty
Pediatrics Blood transfusion
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of safety and efficacy of washed platelet concentrates in pediatric patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of adverse effects
Key secondary outcomes Prevention of transfusion reactions

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 Washed platelet concentration
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 The patients with pediatric hematological disorders who need platelet transfusion
Key exclusion criteria Patients with cardiac, renal, or liver dysfunction
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetaka Shimodaira
Organization Shinshu University Hospital
Division name Transfusion
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-3240
Email shimodai@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigetaka Shimodaira
Organization Shinshu University Hospital
Division name Transfusion
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-3240
Homepage URL
Email shimodai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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 信州大学医学部附属病院(長野県)

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 15 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
2009 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 31 Day
Date of closure to data entry
2011 Year 12 Month 31 Day
Date trial data considered complete
2011 Year 12 Month 31 Day
Date analysis concluded
2011 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 10 Month 09 Day
Last modified on
2014 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003184

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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