UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031481
Receipt No. R000034512
Scientific Title Clinical research to evaluation the safety and efficacy of volume-reduced washed platelets in children with cancer.
Date of disclosure of the study information 2018/02/26
Last modified on 2018/02/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 06 Day
Last follow-up date
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
2018 Year 02 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.