UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036980 |
|---|---|
| Receipt number | R000042052 |
| Scientific Title | Prospective collaborative study on the expression of irregular erythrocyte antibody following erythrocyte transfusion |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2019/07/02 09:26:17 |
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Basic information
Public title
Collaborative study on the expression of irregular erythrocyte antibody following erythrocyte transfusion
Acronym
Post-transfusion irregular erythrocyte antibody
Scientific Title
Prospective collaborative study on the expression of irregular erythrocyte antibody following erythrocyte transfusion
Scientific Title:Acronym
Prospective study on post-transfusion irregular erythrocyte antibody
Region
| Japan |
Condition
Condition
Patients received blood transfusion
Classification by specialty
| Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We are planning multi-center prospective study for seroconversion of erythrocyte irregular antibodies following blood transfusion. We additionally, factors related to the seroconversion.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Erythrocyte irregular antibodies detected following blood transfusion.
2) Factors related seroconversion of antibody following blood transfusion, including sex, age, primary disease, previous transfusion history, amounts of erythrocyte transfused (units) etc.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients transfused for the first time in each institute.
2) Patients received examination for erythrocyte irregular antibody.
3) Written informed consent received from the patient or his/her family.
Key exclusion criteria
1) Rejected his/her informed consent after started this study.
2) The institutional head makes negative decision on this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Takeshita |
Organization
Hamamatsu University School of Medicine
Division name
Transfusion and Cell Therapy
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL
053-435-2111
akihirot@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Harumi |
| Middle name | |
| Last name | Fujihara |
Organization
Hamamatsu University School of Medicine
Division name
Transfusion and Cell Therapy
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan
TEL
053-435-2111
Homepage URL
haru@hama-med.ac.jp
Sponsor or person
Institute
Japan Erythrocyte Irregular Antibody Study Group
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Suppoert Division
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
Tel
053-435-2680
rinri@hama-med.ac.jp
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
全国大学病院輸血部会議技師会（代表 佐賀大学 山田尚友）のうち本研究に参加表明をした施設
日本輸血細胞治療学会認定施設のうち本研究に参加表明をした施設
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective collaborative non-interventional multicenter study for erythrocyte irregular antibodies in Japan.
Management information
Registered date
| 2019 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042052
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
