UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003187
Receipt No. R000003863
Scientific Title Prevention of transfusion reactions with washed platelet concentrates
Date of disclosure of the study information 2010/02/16
Last modified on 2012/08/30

* 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 Prevention of transfusion reactions with washed platelet concentrates
Acronym Prevention of transfusion reactions with washed PC
Scientific Title Prevention of transfusion reactions with washed platelet concentrates
Scientific Title:Acronym Prevention of transfusion reactions with washed PC
Region
Japan

Condition
Condition Hematological diseases
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aim to prevent transfusion reactions using washed PC for patients who experienced them with ordinary PC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decrease in incidence of transfusion reactions with washed PC
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 washed PC
non-washed PC
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient with hematological diseases who has experienced transfusion reactions more than two times.
2. Patient who agrees with this study.
3. Patient who has not have serious complications in heart, kidney, or liver or infections.
4. Patient who was assessed eligible for this study by doctors.
Key exclusion criteria 1. Patient who experienced serious advanced reactions including anaphylactic
reactions.
2. Patinet who has PC transfusion
refractoriness.
3. Patient who uses steroid and antihistamine agents regularly.
4. Patient who was assessed ineligible for this study by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoaki Uruma
Organization Aichi Medical University Hospital
Division name Transfusion Medicine
Zip code
Address Nagakute,Aichi
TEL 0561-62-3311
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoaki Uruma
Organization Aichi Medical University Hospital
Division name Transfusion medicine
Zip code
Address 21,Karimata,Yazako,Nagakute,Aichi
TEL 0561-62-3311
Homepage URL
Email uruma@aichi-med-u.ac.jp

Sponsor
Institute Department of Transfusion Medicine,Aichi Medical 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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 16 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 No longer recruiting
Date of protocol fixation
2009 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 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
2010 Year 02 Month 15 Day
Last modified on
2012 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.