UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003187 |
|---|---|
| Receipt number | 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 12:07:09 |
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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
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
uruma@aichi-med-u.ac.jp
Sponsor or person
Institute
Department of Transfusion Medicine,Aichi Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003863
