UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research to evaluation the safety and efficacy of volume-reduced washed platelets in children with cancer.
Acronym	Clinical research to evaluation the safety and efficacy of volume-reduced washed platelets in children with cancer.
Scientific Title	Clinical research to evaluation the safety and efficacy of volume-reduced washed platelets in children with cancer.
Scientific Title:Acronym	Clinical research to evaluation the safety and efficacy of volume-reduced washed platelets in children with cancer.
Region	Japan

Condition
Condition	children with cancer.
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluation the safety and efficacy of volume-reduced washed platelets in children with cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	corrected count increment after 24hrs
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Replaced platelet concentrates were transfused four times. Replaced platelet concentrates were suspended with conventional volume of solution (two times) and half volume of solution (two times). Conventional volume of solution start.
Interventions/Control_2	Replaced platelet concentrates were transfused four times. Replaced platelet concentrates were suspended with conventional volume of solution (two times) and half volume of solution (two times). Half volume of solution start.
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	20 years-old >
Gender	Male and Female
Key inclusion criteria	Diagnosed as a hematologic malignancy and requires multiple platelet transfusions.
Key exclusion criteria	Platelet transfusion refractory state
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ryu Yanagisawa
Organization	Shinshu University Hospital
Division name	Blood Transfusion
Zip code
Address	Asahi 3-1-1
TEL	0263-37-3240
Email	ryu@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ryu Yanagisawa
Organization	Shinshu University Hospital
Division name	Blood Transfusion
Zip code
Address	Asahi 3-1-1
TEL	0263-37-3240
Homepage URL
Email	ryu@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 26 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	2017 Year 06 Month 06 Day
Date of IRB	2017 Year 06 Month 06 Day
Anticipated trial start date	2017 Year 06 Month 06 Day
Last follow-up date	2020 Year 05 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 26 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034512