UMIN-CTR Clinical Trial

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
Email	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
Email	haru@hama-med.ac.jp

Sponsor
Institute	Japan Erythrocyte Irregular Antibody Study Group
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042052